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