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U.S. Department of Health and Human Services

Class 3 Device Recall Corin Unipolar Adapter Sleeve

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  Class 3 Device Recall Corin Unipolar Adapter Sleeve 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-2144-2009
Recall Event ID 52713
510(K)Number K071471  
Product Classification Prosthesis, hip, hemi-, femoral, metal - Product Code KWL
Product Corin Unipolar Adapter Sleeve, For use with Corin Unipolar CoCr Heads; Not for use w/ceramic heads; not for use w/ Stainless Steel implants.
Stryker Orthopaedics.

Indicated for use in partial hip replacement procedures for patients suffering from pain and disability due to a variety of related bone disease.
Code Information Catalog number: 570-000-01: CORIN UNIPOLAR ADAPTOR SLEEVE JW3MHE 25-Apr-2013 CORIN UNIPOLAR ADAPTOR SLEEVE JXNMHE 25-Apr-2013 CORIN UNIPOLAR ADAPTOR SLEEVE 8DHMJE 17-May-2013 CORIN UNIPOLAR ADAPTOR SLEEVE 8DKMJE 19-May-2013 CORIN UNIPOLAR ADAPTOR SLEEVE 8DVMJE 21-May-2013 
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Colleen O'Meara
201-972-2100
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 24
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 = KWL and Original Applicant = HOWMEDICA OSTEONICS CORP
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