FDA Device

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.

Hazard

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

What You Should Do

Remedy

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.

Products

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.
Brand
Zimmer Inc
UPC
Lot Numbers: 00327200, 55416800 and 60019267.