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U.S. Department of Health and Human Services

Class 2 Device Recall ZMR Porous Revision Hip Prosthesis and ZMR Revision Taper Hip Prosthesis

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  Class 2 Device Recall ZMR Porous Revision Hip Prosthesis and ZMR Revision Taper Hip Prosthesis see related information
Date Initiated by Firm October 21, 2011
Date Posted December 01, 2011
Recall Status1 Terminated 3 on August 29, 2013
Recall Number Z-0322-2012
Recall Event ID 59814
510(K)Number K994286  K031572  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product 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.
Code Information Catalog Number 97-9990-002-00 Revision 2, 2008. All lots for all devices
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact Zimmer Customer Service
800-613-6131
Manufacturer 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.
FDA Determined
Cause 2		 Error in labeling
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.
Quantity in Commerce 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, 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,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = ZIMMER, INC.
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