Zimmer TIV Self Tap Screw, 40 mm. Manufactured by Zimmer Manufacturing B.V., A Subsidiary of Zimmer, Inc., Warsaw, IN; I

FDA device recall Z-0904-2009 · posted 2009-01-26 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

The package may contain a 40 mm long screw instead of the labeled 42 mm long screw, or vice versa.

Action taken

The firm's facility in Japan was notified via letter, "Urgent: Device Recall" (dated 12/11/08) and requested to complete an enclosed Inventory Return Certification form. The letter instructed distributors to notify accounts to the user level to stop using the affected implants and return them to the Zimmer Distribution Center in the U.S. and fax (574-372-4265) a copy of the completed Inventory Return Certification form to Zimmer, Inc. For questions about the recall, please contact Zimmer, Inc. at 1-800-613-6131.

Root cause

Process control

Status

Terminated

Product code

HWC

Quantity affected

100

Distribution

International Distribution including country of Japan.

Date initiated

2008-12-12

Date posted

2009-01-26

Date terminated

2009-10-30

Location

Warsaw, IN