—#30107

Product

Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 5 3/4 inches in length. Catalog # 281-01-14.

FDA product code: JDW — Pin, Fixation, Threaded
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Lot 54008400.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

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.

Timeline

Recall initiated: 2003-10-15
Posted by FDA: 2004-07-20
Terminated: 2004-05-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #30107. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.