Class 2 Device Recall Knowles Pin

• Date Initiated by Firm: October 15, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on May 20, 2004
• Recall Number: Z-0128-04
• Recall Event ID: 27484
• Product Classification: Pin, Fixation, Threaded - Product Code JDW
• Product: Zimmer brand Knowles pin with 3/16 in. threaded diameter, 5/32 in. shaft diameter and 3 inches in length. Catalog # 281-02-03.
• Code Information: Lots 54396700, 55102500, 60008253, 60011141, and 60013753.
• 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: 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.