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U.S. Department of Health and Human Services

Class 2 Device Recall Knowles Pin

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  Class 2 Device Recall Knowles Pin see related information
Date Initiated by Firm October 15, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on May 20, 2004
Recall Number Z-0116-04
Recall Event ID 27484
Product Classification Pin, Fixation, Threaded - Product Code JDW
Product 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.
Code Information Lot Numbers: 00327200, 55416800 and 60019267.
Recalling Firm/
Manufacturer
Zimmer Inc
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact Roy Crowninshield
800-846-4637
Manufacturer Reason
for Recall
The pin may fail because the metal used to make the pin does not meet the firm's hardness specification.
FDA Determined
Cause 2
Other
Action All affected U.S. accounts were sent a letter dated October 15, 2003 by certified mail, return receipt requested. The seven foreign initial consignee accounts were notified via electronic mail. Customers were asked to return non-implanted product and to advise the implanting surgeons of the problem so that they may take appropriate action in regard to their patients.
Distribution The majority of the pins were distributed within the United States. Distribution also occured in seven foreign countries; Taiwan, Canada, Japan, Korea, Belgium, Australia and Finland.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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