Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 3 1/2 inches in length. Catalog # 2

FDA device recall Z-0120-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm

Zimmer Inc

Reason for recall

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

Action taken

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

Status

Terminated

Product code

JDW

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.

Date initiated

2003-10-15

Date posted

2004-07-20

Date terminated

2004-05-20

Location

Warsaw, IN