Date Initiated by Firm | May 29, 2015 |
Date Posted | August 10, 2015 |
Recall Status1 |
Terminated 3 on July 25, 2016 |
Recall Number | Z-2360-2015 |
Recall Event ID |
71677 |
510(K)Number | K141056 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm
Product Usage:
The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, the tibial insert is locked into the tibial baseplate where it serves as the bearing component for the articulating surface of a corresponding Triathlon femoral component. |
Code Information |
Catalog Number 5532-G-511 Lot LD8D7Y Catalog Number 5537-G-319 Lot TT6JT2 |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2006
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For Additional Information Contact | 201-831-5000 |
Manufacturer Reason for Recall | Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Stryker Orthopaedics sent an Urgent Medical Device Recall Notification letter dated July 9, 2015 and Product Accountability Forms via return receipt. The letter identified the affected product, problem, potential hazard, risk mitigation and actions to be taken. Contact Stryker Orthopaedics Sales Representative to arrange for return of the affected product. For questions call 201-831-5826. |
Quantity in Commerce | 26 units |
Distribution | Worldwide Distribution - US Nationwide |
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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