Date Initiated by Firm | January 24, 2013 |
Date Posted | March 18, 2013 |
Recall Status1 |
Terminated 3 on May 06, 2015 |
Recall Number | Z-0964-2013 |
Recall Event ID |
64456 |
510(K)Number | K053514 |
Product Classification |
orthopedic manual surgical instrument - Product Code LXH
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Product | Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE |
Code Information |
Catalog Number: I-K2401KF00 (note each is uniquely identified/marked as IK2401KF0L and IK2401KF0R - Left and Right). Lot Codes: AP5W52 and AP7H19. |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah NJ 07430
|
For Additional Information Contact | Ms. Christie Samsa 201-972-2100 |
Manufacturer Reason for Recall | The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed. |
FDA Determined Cause 2 | Process design |
Action | A Notification Letter/Product Accountability Form dated 01/28/2013 was sent via FedEx on 01/28/2013 to the sole US branch receiving the affected devices. The branch was instructed to also contact the hospitals in its territory that have the affected product to arrange return of the product. Affected products to be returned to Stryker Orthopaedics, 325 Corporate Drive, Mahway, NJ 07430. |
Quantity in Commerce | 4 units (total of 2 sets) |
Distribution | 1 Branch (NJ) with one consignee (DE). |
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 = LXH
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