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U.S. Department of Health and Human Services

Class 2 Device Recall Restoration ADM System

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  Class 2 Device Recall Restoration ADM System see related information
Date Initiated by Firm June 03, 2011
Date Posted November 16, 2011
Recall Status1 Terminated 3 on November 13, 2013
Recall Number Z-0194-2012
Recall Event ID 60097
510(K)Number K072020  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product Stryker Restoration ADM System Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex France

The Restoration ADM is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 22.2 mm and 28 mm diameter femoral heads.
Code Information Catalog No: 1235-2-8XX (XX+48, 50, 52, 54, 56, 58, 60, 63, 64)  All Lots K0272020
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Ms. Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall		 Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used.
FDA Determined
Cause 2		 Labeling False and Misleading
Action The firm, Stryker, sent an "URGENT PRODUCT CORRECTION" letter and Product Correction Bulletin dated June 3, 2011 via Fed Ex to its customers. The letter and bulletin describes the issue, potential hazards, risk mitigation and product correction instructions. The customers were instructed to complete and return the enclosed PRODUCT CORRECTION ACKNOWLEDGMENT FORM within 5 days via fax to: 201-831-6069. If you have any questions, feel free to call (201) 972-2100 or Hip Marketing Team at 201-831-5280.
Quantity in Commerce 13,263 units
Distribution Nationwide distribution.
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 = LZO and Original Applicant = HOWMEDICA OSTEONICS CORP
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