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Terminated

Zimmer brand Knowles pin with 3/16 in. threaded diameter, 5/32 in. shaft diameter and 3 inches in length. Catalog # 281-02-03.

FDA Recall Z-0128-04 · Posted 2004-07-20

Recalling FirmZimmer Inc
Recall StatusTerminated
Product CodeJDW
Date Initiated2003-10-15
Date Terminated2004-05-20

Reason for Recall

The pin may fail because the metal used to make the pin does not meet the firm's hardness specification.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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