Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 58/52, code R, Zimmer, Winterthur, Switzerland; REF 01

FDA device recall Z-2422-2008 · posted 2008-09-26 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

Instructions for use/surgical technique instructions are inadequate.

Action taken

A press release issued on 7/23/08. A letter was sent to implanting surgeons on 7/22/08 advising them of the problem and instructing them to stop implanting these devices until they receive training. Zimmer suspended all marketing and distribution in the U.S. pending completion of user training and revision of the instructions for surgical technique. Zimmer will conduct a removal of all copies of the current surgical technique document and replace it with revised surgical technique document(s). Contact Zimmer, Inc. at 1-866-946-5633 for assistance. Update: A dear surgeon letter was mailed 8/4/08 and provided patient management guidelines. A correction update was sent 8/16/08 with updated surgical technique and instructions for use documents. A dear surgeon letter was mailed 9/25/08 providing additional information regarding the training program.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

KWA

Quantity affected

19,014 of all products.

Distribution

Nationwide.

Date initiated

2008-07-22

Date posted

2008-09-26

Date terminated

2009-10-21

Location

Warsaw, IN

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