January 3, 2001 01-01RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Five Stars Aeroplane brand Palm Seeds in Syrup, in 23-ounce cans. Recall #F-125-1. CODE All codes including LSS 1/10/99 EXP 01/10/2002 & LGS 01/11/99. MANUFACTURER Wang Derm Exporters Ltd., Part., Bangkok, Thailand. RECALLED BY Vasinee Food Corp., Brooklyn, New York (importer), by allergy alert issued on August 22 and 25, 2000, and by letter on August 23, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, New Jersey, Massachusetts, Rhode Island, Pennsylvania. QUANTITY 300 cases (24 cans per case) were distributed. REASON Product contained undeclared sulfites. ________ PRODUCT Various Cheeses: Bulk cheeses in 40-pound blocks: a) Monterey Jack Cheese dated JUN 8 2000 through OCT 25 2000 b) Colby Cheese dated JUN 8 2000 through OCT 25 2000 c) Cheddar Cheese dated JUN 8 2000 through OCT 25 2000 d) Semi Soft Marble Cheese dated JUN 8 2000 through OCT 25 2000 (Marble Cheese is a mixture of Colby and Monterey Jack and can also be called Colby Jack cheese.) e) Muenster Cheese coded/dated "VAT E OCT 3 2000" Retail size packages with individual weights of about one pound and labeled with the brand name "Hill & Valley Cheese, Inc.", the cheese name, and ingredients, and have Hill & Valley Cheese, Inc., Cashton, WI identified as the distributor): f) Colby Cheese, all lots g) Colby-Jack Cheese, all lots h) Mild Cheddar Cheese, all lots i) Monterey Jack Cheese, all lots j) Cheddar Bacon Cheese, all lots k) Vegetable Jack Cheese, all lots l) Onion Jack Cheese, all lots m) Garlic Cheese, all lots n) Caraway Cheese, all lots o) Christmas Cheese, all lots p) Pepper-Jack Cheese, all lots q) Party Pack Cheese, all lots r) Horseradish Cheese, all lots s) Cheese Curds, all lots. Recall #F-126/144-1. CODE See Above. MANUFACTURER Hill & Valley Cheese, Inc., Cashton, Wisconsin. RECALLED BY Manufacturer, by visit on October 17, 2000, and by letters November 2, 13, and 14, 2000. Ongoing recall resulted from sample analysis and follow-up by the Wisconsin Department of Agriculture and Markets. DISTRIBUTION Nationwide. QUANTITY 1,325,000 pounds. REASON Products may be contaminated with Listeria monocytogenes.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Low Carb World Inc., brand Muffins (10 varieties), in packages containing 6 individual 2.5-ounce muffins: Apple, Blueberry, Cherry, Marble, Plain, Lemon, Poppy, Banana, Brownie, Carrot and, Chocolate. Recall #F-145/155- 1. CODE None. All product on market at time of recall initiation. MANUFACTURER Low Carb World Inc., Miami, Florida. RECALLED BY Manufacturer, by telephone beginning August 10, 2000, and by letter on October 12, 2000. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY Approximately 1,500 retail containers were distributed. REASON The muffins contained undeclared FD&C Yellow No. 5 and sodium saccharin which is not permitted for use in this type of product. Additionally, the serving size and the daily values on the Nutrition Facts panel are incorrect in that the declared values are less than half of what they should be.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Tortilleria Mexicana brand Mexican Corn Tortillas, 32 ounces, (907 g). Recall #F-123-1. CODE None. All product on market at time of recall initiation. MANUFACTURER Tortilleria Mexicana, also known as Los Hermanos, Brooklyn, New York. RECALLED BY Manufacturer, by visit on March 16, 2000. Completed field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 77 cases (30 packages per case) were distributed. REASON Product contained undeclared FD&C Blue No. 2 and FD&C Red No. 40. ________ PRODUCT Watsonís Cherry Cordials, in 8-ounce and 16-ounce boxes. Recall #F-124-1. CODE None. All product on market at time of recall initiation. MANUFACTURER Watsonís Candies, Inc., Tonawanda, New York. RECALLED BY Manufacturer, by telephone on April 27, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 47 boxes were distributed. REASON Product contained undeclared benzoic acid, potassium sorbate, and caffeine. ________ PRODUCT Blue Ridge brand Macaroni Salad, in 10-pound rigid plastic containers. Recall #F-156-1. CODE Sell by May 29. MANUFACTURER Blue Ridge Farms, Inc., Brooklyn, New York. RECALLED BY Manufacturer, by letter sent on July 5, 2000. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 736 10-pound containers were distributed; firm estimates none remains on the market. REASON Product contained undeclared potassium sorbate.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT Collyrium Eye Wash, (Boric Acid) in 4-fluid ounce (118 mL) bottles, OTC aqueous ophthalmic solution indicated for cleansing the eye, under the Wyeth and Bausch & Lomb labels. Recall #D-071-1. CODE Wyeth Laboratories, Inc. labeled product bearing lot numbers: 3981543 EXP 6/01; 3982156 EXP 6/01; 3982217 EXP 6/01; Bausch & Lomb labeled product bearing lot numbers: 3982224 EXP 7/01; 3982225 EXP 8/01; 3982226 EXP 9/01; 3991526 EXP 1/02; 3991172 EXP 1/02; 3991269 EXP 4/02; 3990414 EXP 7/02. MANUFACTURER Wyeth-Ayerts Pharmaceuticals, Inc., Rouses Point, New York (contract manufacturer). RECALLED BY Bausch & Lomb, Inc., Rochester, New York, by letter dated December 13, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Volume of product in commerce: Lot 3981543: 26,256 bottles Lot 3982156: 79,032 bottles Lot 3982217: 78,636 bottles Lot 3982224: 78,684 bottles Lot 3982225: 78,612 bottles Lot 3982226: 78,888 bottles Lot 3991526: 78,828 bottles Lot 3991172: 77,484 bottles Lot 3991269: 78,348 bottles Lot 3990414: 49,656 bottles. REASON Phenol contamination (labeling component migration across the container wall).RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT Red Blood Cells. Recall #B-078-1. CODE Unit #3947869. MANUFACTURER Houchin Blood Services, Bakersfield, California. RECALLED BY Manufacturer, by visit on April 15, 1999. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Recovered Plasma. Recall #B-306-1. CODE Unit #7598750. MANUFACTURER Department of Air Force, Lackland AFB, Texas. RECALLED BY Manufacturer, by letter dated March 2, 1999, and by telephone on November 16, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product tested negative for anti-HCV, but was collected from a donor who previously tested reactive for anti-HCV. ________ PRODUCT a) Platelets, Pheresis; b) Platelets, Pheresis, Leukocytes Reduced. Recall #B-320/321-1. CODE Unit Numbers: a) 40P76511 (two units), 40P76598, 40P76611 b) 40P76492, 40P76493, 40P76494 (two units), 40P76495, 40P76496 (two units), 40P76497, 40P76498, 40P76499 (two units), 40P76501, 40P76502, 40P76504, 40P76505, 40P76506, 40P76507 (two units), 40P76508, 40P76510 (two units), 40P76512 (two units), 40P76513 (two units), 40P76514, 40P76515 (two units), 40P76516 (two units), 40P76517, 40P76518, 40P76519 (two units), 40P76520 (two units), 40P76522, 40P76523 (two units), 40P76525 (two units), 40P76526 (two units), 40P76527, 40P76528, 40P76529 (two units), 40P76530, 40P76531 (two units), 40P76533 (two units), 40P76534, 40P76535, 40P76537, 40P76538 (two units), 40P76540, 40P76541 (two units), 40P76542 (two units), 40P76543, 40P76544, 40P76545 (two units), 40P76546 (two units), 40P76547, 40P76548, 40P76549 (two units), 40P76550 (two units), 40P76551, 40P76552, 40P76553, 40P76555, 40P76556, 40P76557 (two units), 40P76558, 40P76559, 40P76560, 40P76561, 40P76563 (two units), 40P76564, 40P76567 (two units), 40P76568 (two units), 40P76569, 40P76570, 40P76571, 40P76572, 40P76573, 40P76574, 40P76575, 40P76576 (two units), 40P76577, 40P76578 (two units), 40P76579, 40P76580 (two units), 40P76581 (two units), 40P76582, 40P76583, 40P76584 (two units), 40P76585, 40P76586 (two units), 40P76587, 40P76589, 40P76590, 40P76591 (two units), 40P76592 (two units), 40P76593, 40P76594, 40P76595, 40P76596, 40P76597, 40P76599, 40P76600, 40P76601, 40P76602 (two units), 40P76603 (two units), 40P76604, 40P76605, 40P76607 (two units), 40P76608, ,40P76609, 40P76610 (two units), 40P76613, 40P76615, 40P76617 (two units), 40P76619 (two units), 40P76622, 40P76623, 40P76624 (two units), 40P76625, 40P76627 (two units), 40P76639, 40P76641, 40P76642, 40P76644, 40P76645. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on June 27, 2000, or letters dated July 3, 2000. Firm-initiated recall complete. DISTRIBUTION Illinois, Missouri, Wisconsin, Arkansas, Michigan, Alabama, Maryland. QUANTITY a) 4 units; b) 202 units were distributed. REASON Platelets were not stored under continuous agitation and controlled temperature. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-348/349-1. CODE Unit Numbers: a) H98449 and T00352; b) T00352. MANUFACTURER Tacoma-Pierce County Blood Bank, doing business as Cascade Regional Blood Services, Tacoma, Washington. RECALLED BY Manufacturer, by letter dated July 24, 2000. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY a) 2 units; b) 1 unit was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Red Blood Cells, Washed. Recall #B-361/363-1. CODE Unit Numbers: a) 22404-2217, 22405-2748; b) 22407-7484; c) 22406-2572. MANUFACTURER Blood Systems, Inc., Las Vegas, Nevada. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated September 1, 1999 or October 18, 1999. Firm-initiated recall complete. DISTRIBUTION Arizona and Nevada. QUANTITY a) 2 units; b) 1 unit; c) 1 unit distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-364-1. CODE Unit #19239-8006. MANUFACTURER Blood Systems, Inc., Reno, Nevada. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on December 29, 1999, and by letter dated January 4, 2000. Firm-initiated recall complete. DISTRIBUTION Nevada. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-367-368-1. CODE Unit #19241-5962. MANUFACTURER Blood Systems, Inc., Reno, Nevada. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 16, 2000. Firm-initiated recall complete. DISTRIBUTION Nevada. QUANTITY 1 unit of each component was distributed. REASON Blood products were distributed after a donor provided post donation information regarding high risk behavior. ________ PRODUCT Red Blood Cells Leukoreduced. Recall #B-371-1. CODE Unit #03GH44546. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by telephone on October 21, 1999, and by letter dated October 27, 1999. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose hematocrit had not been documented. ________ PRODUCT Red Blood Cells. Recall #B-376-1. CODE Unit #2709725. MANUFACTURER Houchin Blood Services, Bakersfield, California. RECALLED BY Manufacturer, by telephone on October 9, 1998, and by letter dated July 25, 2000. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-377-1. CODE Unit #2719929. MANUFACTURER Houchin Blood Services, Bakersfield, California. RECALLED BY Manufacturer, by letter on or about July 15, 1999. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-378-1. CODE Unit #5000326. MANUFACTURER Houchin Blood Services, Bakersfield, California. RECALLED BY Manufacturer, by letter on or about July 1, 1999, and by letter dated July 9, 1999. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-379-1. CODE Unit #3949023. MANUFACTURER Houchin Blood Services, Bakersfield, California. RECALLED BY Manufacturer, by letter dated September 21, 1999. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had traveled to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-380-1. CODE Unit Numbers: 2731465 and 2735920. MANUFACTURER Houchin Blood Services, Bakersfield, California. RECALLED BY Manufacturer, by letters June 15 and 27, or 28 2000. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-381-1. CODE Unit #22405-4411. MANUFACTURER Blood Services, Inc., Las Vegas, Nevada. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated May 19, 1999. Firm-initiated recall complete. DISTRIBUTION Nevada. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-382/383-1. CODE Unit #10593-1280. MANUFACTURER Blood Systems, Inc., Scottsdale, Arizona. RECALLED BY Manufacturer, by letter dated December 13, 1999, or February 2, 1999. Firm-initiated recall complete. DISTRIBUTION Arizona. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-387-1. CODE Unit Numbers: 23142-2628, 23142-2631, 23142-2634, 23142-2641, 23142-2645, 23142-2647, 23142-2648, 23142-2651. MANUFACTURER United Blood Services, Billings, Montana. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on September 26 and 29, 2000, and by letter dated October 23, 2000. Firm-initiated recall complete. DISTRIBUTION Montana and Wyoming. QUANTITY 8 units were distributed. REASON Blood products were collected in a manner that compromised the sterility of the units. ________ PRODUCT Platelets, Pooled. Recall #B-390-1. CODE Unit #PO4542. MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by telephone on February 15, 2000, and by letter dated August 15, 2000. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY 1 unit was distributed. REASON Blood product was not properly filtered. ________ PRODUCT Platelets, Pheresis. Recall #B-391-1. CODE Unit #K10868. MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, Louisiana. RECALLED BY Manufacturer, by telephone on July 8, 1998. Firm-initiated recall complete. DISTRIBUTION Louisiana. QUANTITY 1 unit was distributed. REASON Blood product was collected in a bag that had a tab cover that came off the sterile port during processing. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-392/393-1. CODE Unit #FL05504. MANUFACTURER Central Illinois Community Blood Bank, Springfield, Illinois. RECALLED BY Manufacturer, by telephone and fax on August 4 and 7, 2000. Firm- initiated recall complete. DISTRIBUTION Illinois and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of Multiple Sclerosis. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-402/403-1. CODE Unit Numbers: a) 3768914 and 3768921; b) 3768914. MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY Manufacturer, by fax on April 3, 2000. Firm-initiated recall complete. DISTRIBUTION Texas, Pennsylvania, New Jersey. QUANTITY a) 2 units; b) 1 unit. REASON Blood products were collected from donors who had lived in the Central African Republic. ________ PRODUCT Recovered Plasma. Recall #B-404-1. CODE Unit #0707759. MANUFACTURER Blood Centers of the Pacific, San Francisco, California. RECALLED BY Manufacturer, by letter dated July 29, 1999. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was untested for viral markers. ________ PRODUCT Red Blood Cells. Recall #B-405-1. CODE Unit #3672814. MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY Manufacturer, by fax dated September 30, 1999. Firm-initiated recall complete. DISTRIBUTIN Texas. QUANTITY 1 unit was distributed. REASON Blood product tested positive for the Kell antigen, but was labeled as Kell antigen negative. ________ PRODUCT Fresh Frozen Plasma. Recall #B-406-1. CODE Unit #3777994. MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY Manufacturer, by fax dated April 12, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product tested negative for the antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but was collected from a donor who was not asked questions intended to determine whether the donor participated in activities at an increased risk of infection with HIV. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-407/408-1. CODE Unit #2708080. MANUFACTURER Houchin Community Blood Bank, Bakersfield, California. RECALLED BY Manufacturer, by telephone and fax on July 30, 1998. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood products tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from an unsuitable donor due to behavior known to increase the risk of infection with HIV.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Platelets, Pheresis, Leukocytes Reduced. Recall #B-369-1. CODE Unit Numbers: 19239-4859 and 19239-4896. MANUFACTURER Blood Systems, Inc., Reno, Nevada. RECALLED BY Blood systems, Inc., Scottsdale, Arizona and Blood Systems, Inc., Reno, Nevada, by telephone on August 10 or 20, 1999, and by letters dated August 23, 1999. Firm-initiated recall complete. DISTRIBUTION Texas and Nevada. QUANTITY 2 units were distributed. REASON Blood products were labeled with extended expiration dates. ________ PRODUCT Cryoprecipitate AHF. Recall #B-370-1. CODE Unit #E22859. MANUACTURER Carolina-Georgia Blood Center, Inc., Greenville, South Carolina. RECALLED BY Manufacturer, by letter dated July 28, 1999. Firm-initiated recall complete. DISTRIBUTION South Carolina. QUANTITY 1 unit was distributed. REASON Blood product was manufactured from a unit of plasma, that had been produced from a unit of Whole Blood that had an extended collection time, and was not frozen within eight hours of phlebotomy. ________ PRODUCT Red Blood Cells, Irradiated. Recall #B-386-1. CODE Unit Numbers: G65059, G65073, G64790, G64763, G64878, S96532. MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, Iowa. RECALLED BY Manufacturer, by telephone on February 29, 2000. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 6 units were distributed. REASON Blood products were labeled with extended expiration dates. ________ PRODUCT a) Panocell-10 Reagent Red Blood Cells, b) Panocell-10, Ficin Treated Reagent Red Blood Cells. Recall #B-409/410-1. CODE Lot Numbers: a) 24637 and 34875; b) 24637-E. MANUFACTURER Immucor, Inc., Norcross, Georgia. RECALLED BY Manufacturer, by letter on August 22, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY Over 700 antibody identification panels were distributed. REASON Reagent Red Blood Cells tested positive for the P1 antigen, but were labeled negative for the P1 antigen. ________ PRODUCT Red Blood Cells. Recall #B-416-1. CODE Unit #4709772. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by telephone and by letter on March 24, 2000. Firm- initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose hematocrit was not determined. ________ PRODUCT Platelets. Recall #B-429-1. CODE Unit #6536816. MANUFACTURER Michigan Community Blood Centers, Grand Rapids, Michigan. RECALLED BY Manufacturer, by letter dated November 17, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had taken the medication tetracycline.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT Immulite brand Total T3 Test Kit, in-vitro diagnostic device: a) Catalog #LKT31, 100 test kit; b) Catalog #LKT35, 50 test kit. Recall #Z-120/121-1. CODE Lot #202. MANUFACTURER Diagnostics Products Corporation, Los Angeles, California. RECALLED BY Manufacturer, by letter on September 15, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY a) 284 kits; b) 60 kits were distributed. REASON An additional piece of labeling, an "Important Notice" was included in the kit and it instructed the customer to use control target values that differed from the package insert instructions. ________ PRODUCT Scorpio TS Total Knee Tibial Tray, part of the Osteonics Scorpio Total Knee System that includes the femoral, patellar, tibial bearing insert, bone augmentation and components which are designed to be used together for total reconstructive replacement of the knee joint. Catalog #77-4003 through 77-4013. Recall #Z-142-1. CODE Catalog No. Lot No. 77-4003 T00E251, T00K434 77-4005 T00E253, T00E256, T00257, T00K384 77-4007 T00E258, T00E259,T00E260,T00E262,T00K387 77-4009 T00E263, T00E264,T00E265, T00E267,T00L663 77-4011 T00E268, T00E269, T00K441, T00L664 77-4013 T00E274, T00K443, T00K444. MANUFACTURER Howmedica Osteonics Corporation, Allendale, New Jersey. RECALLED BY Manufacturer, by letter on September 13, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 88 units were distributed. REASON The screw hole plugs became dislodged during implantation.END OF ENFORCEMENT REPORT FOR JANUARY 3, 2001. ####
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