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U.S. Department of Health and Human Services

Class 3 Device Recall Restoration Modular Calcar Body

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  Class 3 Device Recall Restoration Modular Calcar Body see related information
Date Initiated by Firm June 26, 2009
Date Posted September 14, 2009
Recall Status1 Terminated 3 on July 27, 2010
Recall Number Z-2178-2009
Recall Event ID 52713
510(K)Number K013106  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product Restoration Modular Calcar Body, 21 mm +20 mm;
Stryker Orthopaedics.

Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
Code Information Catalog number: 6276-4-221; REST MOD CALCAR BODY 21mm +20mm T80551AA 28-Jan-2014 REST MOD CALCAR BODY 21mm +20mm T80551AA 28-Jan-2014 REST MOD CALCAR BODY 21mm +20mm T80551AA 28-Jan-2014 REST MOD CALCAR BODY 21mm +20mm T80551AA 28-Jan-2014 
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Colleen O'Meara
Manufacturer Reason
for Recall
The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by this vendor has raised concern about their supplied raw material. As a precaution and due to the potential impact on the mechanical properties of the products, St
FDA Determined
Cause 2
Nonconforming Material/Component
Action Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.
Quantity in Commerce 203 - all varieties
Distribution Worldwide 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.