ZMR Porous Revision Hip Prosthesis Surgical Technique, utilized for the following ZMR devices: Porous Stem,Nitrited Poro

FDA device recall Z-0322-2012 · posted 2011-12-01 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use.

Action taken

The firm Zimmer, sent an "URGENT DEVICE CORRECTION" letter dated August 26, 2011 to Marketing Personnel, Distributors, Sales Representatives, Distribution Operation Managers, and Surgeons. The letters identified the reason for the recall, the product, and required actions to be taken. The letter also included Medwatch reporting information and a Certificate of Acknowledgement form to fax back to the recalling firm to confirm receipt of the recall notice. For questions contact Zimmer at 1-877-946-2761.

Root cause

Error in labeling

Status

Terminated

Product code

LPH

Quantity affected

119,284 total devices

Distribution

Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dubai/UAE, Eschba

Date initiated

2011-10-21

Date posted

2011-12-01

Date terminated

2013-08-29

Location

Warsaw, IN

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