Date Initiated by Firm | April 16, 2009 |
Date Posted | July 23, 2009 |
Recall Status1 |
Terminated 3 on April 05, 2010 |
Recall Number | Z-1608-2009 |
Recall Event ID |
52072 |
510(K)Number | K070095 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | Offset Adaptor Trial - 4MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430.
Indications for use include disabling joint disease of the knee. |
Code Information |
Catalog number 5570-T-040; All Lot Numbers. |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430
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For Additional Information Contact | Colleen O'Meara 201-831-5000 |
Manufacturer Reason for Recall | Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool. |
FDA Determined Cause 2 | Process control |
Action | "Urgent Product Correction" letters dated April 16, 2009 were sent to all Stryker Representatives, Hospital Rick Management Departments, Hospital Chief of Orthopaedics, Surgeon and countries by Federal Express. The notice explains the Issue, Potential Hazards and Risk Mitigation Factors of the affected product(s) including a request to complete and return the Product Correction Form.
For further questions, contact Stryker Orthopedics, Division of Regulatory Reporting at 201-831-5970. |
Quantity in Commerce | 2498 total units, all sizes |
Distribution | Worldwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JWH
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