Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach, Size 7, 8, nonsterile; REF 5997-61-07. A reusable cut

FDA device recall Z-1262-2009 · posted 2009-05-12 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

The surface finish inside of the broach is not to specification and the instrument may corrode if cleaned and sterilized according to instructions.

Action taken

Distributors were notified by an "Urgent: Device Recall" letter dated March 13, 2009. The letter described the affected product, reason for recall, health risks and actions for distributors and user facilities. Customers were instructed to quarantine affected instruments and return them to the Zimmer Product Service Department. Distributors were also instructed to provide the name and address of hospitals where the instruments were used so that a copy of the recall letter can be forwarded to the user facilities. Direct questions about this recall to Zimmer, Inc. by calling 800-613-6131.

Root cause

Finished device change control

Status

Terminated

Product code

HTQ

Quantity affected

37

Distribution

Worldwide Distribution -- US, Australia, and Germany.

Date initiated

2009-03-13

Date posted

2009-05-12

Date terminated

2009-12-22

Location

Warsaw, IN