FDA

Enforcement Report

November 26, 2003
03-48

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
Dominick's Chili Beans Mexican Style; Net Wt. 15 oz. cans, 24 cans per case; UPC #38281-06124. Recall # F-032-4.
CODE
Embossed code: G3H17/1BCTB Ink code: Best By 07 20 05.
RECALLING FIRM/MANUFACTURER
Hoopeston Foods, Inc., Bloomington, MN, by telephone on September 24, 2003, and by e-mail on September 25, 2003. Firm initiated recall is ongoing.
REASON
Canned chili beans contain undeclared wheat flour and soybean oil.
VOLUME OF PRODUCT IN COMMERCE
85 cases.
DISTRIBUTION
IL.
______________________________
PRODUCT
a) Eden Organic Apple Juice. Recall # F-033-4;
b) Eden Organic Apple Juice. Recall # F-034-4.
CODE
a) Lot 114355 (32 fl. oz. and 64 fl. oz.),
Lot 214315 (32 fl. oz. and 750 ml),
Lot 214322 (64 fl. oz. and 1.82 L);
b) 02316-01 and 02317-01.
RECALLING FIRM/MANUFACTURER
Eden Foods, Inc., Clinton, MI, by letter on July 29, 2003 and August 12, 2003. Firm initiated recall is ongoing.
REASON
Products contain elevated patulin.
VOLUME OF PRODUCT IN COMMERCE
38,592 bottles.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Apple Juice packed into glass bottles with a paper label which states: Lakewood Organic Fresh Pressed Apple Juice 32 Fl. Oz. Recall # F-035-4.
CODE
Any product coded with the first three digits of "96X", "96W", or "99W".
RECALLING FIRM/MANUFACTURER
Florida Bottling, Inc., Miami, FL, by letter on July 24, 2003. FDA initiated recall is complete.
REASON
Product contains elevated patulin.
VOLUME OF PRODUCT IN COMMERCE
136 cases, 12 bottles per case.
DISTRIBUTION
FL, and NY.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
Midland Farms brand "PINK LEMON DRINK" in 1 gallon plastic jugs. Recall # F-036-4.
CODE
All lots with a SELL BY date of DEC 31 or earlier and plant code of 36-1661 stamped on the jug.
RECALLING FIRM/MANUFACTURER
Midland Farms Inc., Menands, NY, by telephone on October 22, 2003. FDA initiated recall is ongoing.
REASON
The product contains undeclared color, FD&C Red 40.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
MA, NY, and RI.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

____________________________
PRODUCT
TechneScan MAA, Technetium TC 99m Albumin Aggregated Injection and Kit (Lyophilized), Kit for the preparation of Technetium Tc 99m Albumin Aggregated, Rx Only, packaged in 5-vial kits or 30-vial kits. Recall # D-058-4.
CODE
Lot Number/Exp. Date:
0932024, Exp. 9/18/03;
0932026, Exp. 9/25/03;
0932027, Exp. 9/30/03;
0932028, Exp. 10/7/03;
0932030, Exp. 10/16/03;
0932031, Exp. 10/21/03;
0932032, Exp. 10/28/03;
0932033, Exp. 10/30/03;
0932034, Exp. 11/13/03;
0932035, Exp. 11/20/03;
0932036, Exp. 11/25/03,
0932037, Exp. 12/3/03;
0932038, Exp. 12/9/03;
0932039, Exp. 12/18/03;
0933001, Exp. 1/6/04;
0933005, Exp. 3/10/04;
0933006, Exp. 3/12/04;
0933007, Exp. 3/17/04;
0933008, Exp. 3/24/04;
0933009, Exp. 3/26/04;
0933010, Exp. 3/31/04;
0933013, Exp. 5/19/04;
0933014, Exp. 5/21/04;
0933015, Exp. 6/2/04;
0933016, Exp. 6/4/04;
0933018, Exp. 6/25/04;
0933019, Exp. 7/7/04.
RECALLING FIRM/MANUFACTURER
Mallinckrodt, Inc., Maryland Heights, MO, by letter dated September 23, 2003. FDA initiated recall is ongoing.
REASON
Good Manufacturing Practice Deviations (GMPs) leading to product process variability within the manufacturing/sterility/validation process(es) which result in poor diagnostic scans (including but not limited to altered biodistribution/radiochemical impurity).
VOLUME OF PRODUCT IN COMMERCE
98,495 vials.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Comtrex SOFTGELS, Multi-Symptom, Deep Chest Cold, Pain Reliever/Fever Reducer, Expectorant, Cough Suppressant, Nasal Decongestant, 20 and 30 softgel capsule cartons. Active ingredients: Acetaminophen 250 mg., DexProduct Description (Label/Packaging) tromethorphan HBr 10 mg., Guaifenesin 100 mg., Pseudoephedrine HCl 30 mg. Recall # D-059-4.
CODE
20 Count Package, Lot Number/Expiration Date; 205564 Feb 04, 205601 Feb 04, 205602 Feb 04, 207549 Feb 04, 207550 May 04, 207551 June 04, 207598 June 04, 208557 June 04, 208558 June 04, 208559 June 04, 210503 June 04, 210504 June 04, 210505 June 04, 210506 July 05, 210507 July 05, 210508 July 05, 210509 July 05, 210510 July 05, 210532 July 05, 210533 Aug 04, 210593 July 04, 210594 Aug 04, 210595 Aug 04, 210622 July 04, 301507 May 04, 301508 Nov 04, 301556 Nov 04, 301557 Nov 04, 301558 Nov 04, 302578 Dec 04, 302579 Dec 04, 302580 Dec 04, 302592 Dec 04, 303567 Dec 04, 308511 May 05. 30 Count Package, Lot Number/Expiration Date; 306588 May 05, 308510 May 05, 308535 May 05, 309538 July 05, 309544 July 05. Display Number 1018: A3H1A May 05, A3H1C, May 05 Display Number 1081: A3H1A May 05.
RECALLING FIRM/MANUFACTURER
Bristol-Myers Squibb Co., Hillside, NJ, by letter on October 1, 2003. Firm initiated recall is ongoing.
REASON
Mis-Labeling: The dosing instructions incorrectly declare a maximum dose of 12 caps per 24 hour period (the maximum recommended dose should read 8 caps per 24 hour period).
VOLUME OF PRODUCT IN COMMERCE
67,706 packages.
DISTRIBUTION
Nationwide and Trinidad.

_______________________________
PRODUCT
Kaletra capsules (Lopinavir/Ritonavir), Each soft gelatin capsule contains: Lopinavir 133.3mg, Ritonavir 33.3mg, 180 capsule bottles, Rx only. Recall # D-060-4.
CODE
Lot 852072E25 Lot 852002E21.
RECALLING FIRM/MANUFACTURER
Jam Pharmaceutical, Orange, CA, by letter dated October 17, 2003. FDA initiated recall is ongoing.
REASON
Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
a) DON'T BE BALD Hair Care Treatment, Medicated, "THE
ORIGINAL FORMULAS", Net. Wt. 4 oz. Jars.
Recall # D-065-4;
b) BBD 1854 Dandruff Shampoo, For Professional Use Only,
Anti-Dandruff Conditioning Shampoo, 8 Fl. Oz. bottles
(24 Liters). Recall # D-066-4;
c) Don't B Bald, Scalp Stimulate, Organic Formula, 4 Fl.
Oz. (118 mL) Jars. Recall # D-067-4.
CODE
a) Batch numbers: 55, 64, and 69;
b) Batch number: 10269;
c) Batch numbers: 020800, 53.
RECALLING FIRM/MANUFACTURER
Pride and Power, Inc., Houston, TX, by letter on September 30, 2003. FDA initiated recall is ongoing.
REASON
Unapproved New Drug.
VOLUME OF PRODUCT IN COMMERCE
5,580 containers.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Morphine Sulfate (Immediate Release) Concentrated Oral Solution, 20 mg per mL, 30 mL bottle and dropper, Rx Only. Recall # D-068-4.
CODE
Lot No: 47472.
RECALLING FIRM/MANUFACTURER
Ethex Corporation, Bridgeton, MO, by letter on October 31, 2003. Firm initiated recall is ongoing.
REASON
Mislabeling: Correctly labeled Oxydose Oral Concentrate Solution (20mg/1mL) bottles were mispackaged in holding cartons labeled as Morphine Sulfate.
VOLUME OF PRODUCT IN COMMERCE
12,250 bottles Oxydose.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Platelets, Pheresis. Recall # B-0285-4.
CODE
Units 0883909A, 0883909B.
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center, Inc., Jackson, TN, by
telephone on November 3, 2000. Firm initiated recall is complete.
REASON
Blood products, with a decreased platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Source Plasma. Recall # B-0287-4.
CODE
Units 46DCLKZGAB, 46DCKNQDAB, 46DCKNMGAB, 46DCKNLGAB, 46DCKNKHAB, 46DCKMZMAB, 46DCKMYMAB, 46DCKMXQAB, 46DCKMWSAB, 46DCKMTNAB, 46DCKMTDAB, 46DCKMPSAB, 46DCGSVPAB, 46DCGSTQAB, and 46DCGSTGAB.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc. Decatur, IL, by facsimile on June 19, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of body piercing, were as distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0288-4.
CODE
Unit 9399264.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated May 23, 2001. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was deferred for receiving a tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Source Plasma. Recall # B-0315-4.
CODE
Unit number 38737084.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Corpus Christi, TX , by telephone on December 6, 2000. Firm initiated recall is complete.
REASON
Blood product, manufactured in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0317-4.
CODE
Unit number 22LV95821.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on July 14, 2003, and by letter on July 25, 2003. Firm initiated recall is complete.
REASON
Blood product, corresponding to a blood product that was possibly contaminated with Staphylococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0318-4;
b) Platelets. Recall # B-0319-4.
CODE
a) and b) Unit number 13GV35969.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on May 5, 2003, and by letter on May 8, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0320-4.
CODE
Unit number 13FK14653.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on September 15, and by letter on September 16, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0286-4.
CODE
Units 53GC43434, 53GC43444, 53LL58237, 53LL58240, 53GQ97626, 53Q95102.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD, by letter dated July 17, 2002. Firm initiated recall is complete.
REASON
Blood products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
MD.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
OEC UroView 2800 Digital Imaging System.
Recall # Z-0604-03.
CODE
Manufacturing date prior to September 9, 2002.
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems, Inc., Salt Lake City, UT, by service technician visit beginning on November 13, 2003. Firm initiated recall is ongoing.
REASON
"Condition 1": Involving systems, manufactured prior to June 25, 2002, that include the optional 15 pulse per second fluoroscopic mode. In these systems, it is possible for the maximum entrance exposure rate (EER) to exceed the regulatory limit of 20 R/minute in high-level control (HLC) mode.
"Condition 2": Involving systems equipped with radiographic spot film mode manufactured prior to September 9, 2002. This condition is met when the FILM button is not held down continuously until the adjacent LED remains lit and control panel display indicates FILM MODE READY, causing the system to not readjust the x-ray field size to the proper fluoroscopic setting for fluoroscopic procedures. When this occurs, the x-ray field size for any subsequent fluoroscopic exposures may be larger than the patient anatomy being viewed.
VOLUME OF PRODUCT IN COMMERCE
153 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
LySonix 2000 Ultrasonic Surgical Systems, Model No. LY-2000. Recall # Z-0070-04.
CODE
Serial numbers between 0100 and 1219 (inclusive).
RECALLING FIRM/MANUFACTURER
Misonix, Inc., Farmingdale, NY, by letter on August 13, 2003, and September 17, 2003. Firm initiated recall is ongoing.
REASON
Firm received complaints of tingling or static shock sensation to end users caused by forcing the output connector into its receptacle misaligned. The misalignment causes additional voltage to appear on the patient probe.
VOLUME OF PRODUCT IN COMMERCE
1,119 units (approx.).
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
PeriVac( brand Pericardial Fluid Aspiration Procedure Kit (Pericardiocentensis Kit), with Pigtail Drainage Catheter; Model/Catalog Numbers: 4304 and 4305. Recall # Z-0071-04.
CODE
Batch numbers: All units of this models; UPN numbers: M00443041, M00443051, M00443040, M00443050.
RECALLING FIRM/MANUFACTURER
Boston Scientific, San Jose, CA, by letter on September 22, 2003. Firm initiated recall is ongoing.
REASON
The product has the potential to break during withdrawal process.
VOLUME OF PRODUCT IN COMMERCE
11,835 units.
DISTRIBUTION
Nationwide, and Internationally.

_______________________________
PRODUCT
a) Belos DR Implantable Cardioverter Defibrillator.
Recall # Z-0072-04;
b) Belos DR-T Implantable Cardioverter Defibrillator.
Recall # Z-0073-04;
c) Belos VR Implantable Cardioverter Defibrillator.
Recall # Z-0074-04;
d) Belos VR-T Implantable Cardioverter Defibrillator.
Recall # Z-0075-04.
CODE
a) Serial Number 79610175;
b) Serial Numbers: 79640026, 79640028, 79640030,
79640031, 79640032, 79640033, 79640035, 79640037,
79640039, 79640044, 79640048, 79640049, 79640053,
79640058, 79640060, 79640062, 79640064, 79640065,
79640070, 79640078, 79640079, 79640080, 79640081,
79640082, 79640085, 79640086, 79640087, 79640088,
79640089, 79640091, 79640093, 79640094, 79640095,
79640097, 79640104, 79640116, 79640117, 79640121,
79640239, 79640247, 79640252, 79640323, 79640324.
c) Serial Numbers: 78112903, 78112904, 78112905,
78112906, 78112907, 78112908, 78112909, 78113004,
78113012, 78113013, 78113014, 78113015, 78113016,
78113017, 78113018, 78113019, 78113020, 78113022,
78113054, 78113055, 78113057, 78113058, 78113059,
78113060, 78113061, 78113062, 78113063, 78113064,
78113066, 78113067, 78113071, 78113082, 78113084,
78113085, 78113086, 78113090, 78113091, 78113092,
78113093, 78113094, 78113095, 78113096, 78113113,
78113114, 78113115, 78113116, 78113117, 78113118,
78113119, 78113120, 78113121, 78113122, 78113123,
78113124.
d) Serial Numbers: 78140141, 78140145, 78140146,
78140147, 78140148, 78140150, 78140151, 78140152.
RECALLING FIRM/MANUFACTURER
Biotronik, Inc., Lake Oswego, OR, by letter dated September 24, 2003. Firm initiated recall is ongoing.
REASON
Potential extended charge time anomalies.
VOLUME OF PRODUCT IN COMMERCE
106 devices.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Belos VR Implantable Cardioverter Defibrillator (ICD)
with version A-K00.1.U/1 programmer software.
Recall # Z-0076-04;
b) Belos VR-T Implantable Cardioverter Defibrillator (ICD)
with version A-K00.1.U/1 programmer software.
Recall # Z-0077-04.
CODE
a) Serial Numbers: 7811xxxx;
b) Serial Numbers: 7814xxxx.
RECALLING FIRM/MANUFACTURER
Biotronik, Inc., Lake Oswego, OR, by letter dated September 24, 2003. Firm initiated recall is ongoing.
REASON
Potential for early depletion of Implantable Cardioverter Defibrillator battery.
VOLUME OF PRODUCT IN COMMERCE
1,066 devices.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
LithoClast Foot Pedal, reference EK-166 Catalog Number: 840-703. Used as an accessory to the EMS Swiss LithoClast Master/Ultra, Catalog No 840-700. Recall # Z-0078-04.
CODE
Units shipped prior to 3/03.
RECALLING FIRM/MANUFACTURER
Electro Medical Systems (EMS SA), Nyon, CH, by letter dated October 3, 2003, and October 6, 2003. Firm initiated recall is ongoing.
REASON
Failure of foot pedal to activate device.
VOLUME OF PRODUCT IN COMMERCE
96 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649 Recall # Z-0087-04.
CODE
Lot number: Y072103-3.
RECALLING FIRM/MANUFACTURER
Rita Medical Systems, Mountain View, CA, by letters on October 6, 2003. Firm initiated recall is ongoing.
REASON
The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading.
VOLUME OF PRODUCT IN COMMERCE
137 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Terumo Advanced Perfusion System 1 Roller Pump; 4 inch
diameter; Catalog number 801040. Recall # Z-0102-04;
b) Terumo Advanced Perfusion System 1 Roller Pump; 6 inch
diameter; Catalog number 801040. Recall # Z-0103-04.
CODE
a) and b) Serial numbers 0001 through 0599.
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letters on October 16, 2003. Firm initiated recall is ongoing.
REASON
The roller pump tube clamp mechanism may fail to release, making it difficult to remove or insert the tubing, and thereby delaying perfusion.
VOLUME OF PRODUCT IN COMMERCE
548.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Zimmer brand Knowles pin with 5/32 in. threaded
diameter, 1/8 in. shaft diameter and 2 1/2 inches in
length. Catalog # 281-01-01. Recall # Z-0116-04;
b) Zimmer brand Knowles pin with 5/32 in. threaded
diameter, 1/8 in. shaft diameter and 2 3/4 inches in
length. Catalog # 281-01-02. Recall # Z-0117-04;
c) Zimmer brand Knowles pin with 5/32 in. threaded
diameter, 1/8 in. shaft diameter and 3 inches in length.
Catalog # 281-01-03. Recall # Z-0118-04;
d) Zimmer brand Knowles pin with 5/32 in. threaded
diameter, 1/8 in. shaft diameter and 3 1/4 inches in
length. Catalog # 281-01-04. Recall # Z-0119-04;
e) Zimmer brand Knowles pin with 5/32 in. threaded
diameter, 1/8 in. shaft diameter and 3 1/2 inches in
length. Catalog # 281-01-05. Recall # Z-0120-04;
f) Zimmer brand Knowles pin with 5/32 in. threaded
diameter, 1/8 in. shaft diameter and 3 3/4 inches in
length. Catalog # 281-01-06. Recall # Z-0121-04;
g) Zimmer brand Knowles pin with 5/32 in. threaded
diameter, 1/8 in. shaft diameter and 4 inches in length.
Catalog # 281-01-07.Recall # Z-0122-04;
h) Zimmer brand Knowles pin with 5/32 in. threaded
diameter, 1/8 in. shaft diameter and 4 1/4 inches in
length. Catalog # 281-01-08. Recall # Z-0123-04;
i) Zimmer brand Knowles pin with 5/32 in. threaded
diameter, 1/8 in. shaft diameter and 4 3/4 inches in
length. Catalog # 281-01-10.Recall # Z-0124-04;
j) Zimmer brand Knowles pin with 5/32 in. threaded
diameter, 1/8 in. shaft diameter and 5 inches in length.
Catalog # 281-01-11. Recall # Z-0125-04;
k) Zimmer brand Knowles pin with 5/32 in. threaded
diameter, 1/8 in. shaft diameter and 5 3/4 inches in
length. Catalog # 281-01-14. Recall # Z-0126-04;
l) Zimmer brand Knowles pin with 5/32 in. threaded
diameter, 1/8 in. shaft diameter and 6 inches in length.
Catalog # 281-01-15. Recall Z-0127-04;
m) Zimmer brand Knowles pin with 3/16 in. threaded
diameter, 5/32 in. shaft diameter and 3 inches in
length. Catalog # 281-02-03. Recall Z-0128-04;
n) Zimmer brand Knowles pin with 3/16 in. threaded
diameter, 5/32 in. shaft diameter and 3 1/4 inches in
length. Catalog # 281-02-04. Recall Z-0129-04;
o) Zimmer brand Knowles pin with 3/16 in. threaded
diameter, 5/32 in. shaft diameter and 3 1/2 inches in
length. Catalog # 281-02-05. Recall Z-0130-04;
p) Zimmer brand Knowles pin with 3/16 in. threaded
diameter, 5/32 in. shaft diameter and 3 3/4 inches in
length. Catalog # 281-02-06. Recall Z-0131-04;
q) Zimmer brand Knowles pin with 3/16 in. threaded
diameter, 5/32 in. shaft diameter and 4 inches in
length. Catalog # 281-02-07. Recall Z-0132-04;
r) Zimmer brand Knowles pin with 3/16 in. threaded
diameter, 5/32 in. shaft diameter and 4 1/4 inches in
length. Catalog # 281-02-08.Recall Z-0133-04;
s) Zimmer brand Knowles pin with 3/16 in. threaded
diameter, 5/32 in. shaft diameter and 4 1/2 inches in
length. Catalog # 281-02-09. Recall Z-0134-04;
t) Zimmer brand Knowles pin with 3/16 in. threaded
diameter, 5/32 in. shaft diameter and 4 3/4 inches in
length. Catalog # 281-02-10. Recall Z-0135-04.
CODE
a) Lot Numbers: 00327200, 55416800 and 60019267;
b) Lots 54382000, 55444200, 60008252 and 60011140;
c) Lots 54382100, 54396500, 54987200, 55416900, 60010924,
60023409 and 60028438;
d) Lots 53826200, 54382200, 55444300 and 60019268;
e) Lots 00330600, 54162100, 54382300, 55039300, 55147500,
55236100, 55417000, 60013747 and 60019270;
f) Lots 54382400, 54396600, 55039400, 55102400, 55236200,
60013749 and 60024242;
g) Lots 54146500, 54458400, 55039500, 55236300, 60019272
and 60028439;
h) Lots 30003800, 54881700, 55039600, 55236400, 60013751
and 60019275;
i) Lots 55444400 and 60028441;
j) Lot 60033279;
k) Lot 54008400;
l) Lot 54008500;
m) Lots 54396700, 55102500, 60008253, 60011141, and
60013753;
n) Lots 54978600, 60011142 and 60013758;
o) Lots 00041400, 00087800, 54008600, 54162200, 54493900,
55039700, 60004569, 60013760 and 60019282;
p) Lots 60008254, 60013762 and 60019284;
q) Lots 53826300, 54162300, 54382500, 55102600, 55247300,
60011144, 60013765, 60019287, 60025555 and 60035945;
r) Lot 60028449;
s) Lot 60028450;
t) Lots 60028451 and 60031021.
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by letter dated October 15, 2003. Firm initiated recall is ongoing.
REASON
The pin may fail because the metal used to make the pin does not meet the firm's hardness specification.
VOLUME OF PRODUCT IN COMMERCE
4,608.
DISTRIBUTION
Nationwide and Internationally.

END OF ENFORCEMENT REPORT FOR NOVEMBER 26, 2003

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