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Terminated

ZMR Porous Revision Hip Prosthesis Surgical Technique, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splined Straight Stem, Taper Stem and Bodies, Calcar Bodies, and Spout Bodies. Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur.

FDA Recall Z-0322-2012 · Posted 2011-12-01

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2011-10-21
Date Terminated2013-08-29
Product Quantity119,284 total devices

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.

Firm Action

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

Distribution Pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dubai/UAE, Eschbach, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Jordan, Israel, Korea, Lebanon, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Russia, S. Africa, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, and Venezuela,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031572ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923Zimmer, Inc. · 2003-06-24K994286ZMR HIP SYSTEM-POROUS REVISIONZimmer, Inc. · 2000-03-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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