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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon X3 Posterior Stabilized Tibial Insert

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 Class 2 Recall
Triathlon X3 Posterior Stabilized Tibial Insert
see related information
Date Posted March 03, 2009
Recall Status1 Open
Recall Number Z-1013-2009
Recall Event ID 50738
Premarket Notification
510(K) Number
K051146 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Triathlon X3 Posterior Stabilized Tibial Insert Use with Triathlon PS Femoral Components. Sze 7, THKNS 13 m and SZE 8, THKNS 13mm; Catalog number 5532-G-713, Catalog number 5532-G-813 Stryker Orthopaedics
Code Information Lot code LBD528 and Lot code LBD512.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430
For Additional Information Contact Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall
Stryker Orthopaedics became aware of a lot for lot mix-up between part numbers 5532-G-713, lot code LBD528 (Triathlon X3 Posterior Stabilized Tibial Insert, size 7-13 mm) and part 5532-G-813, lot code LBD512 (Triathlon X3 Posterior Stabilized Tibial Insert Size 8-13 mm)
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Urgent Product Recall letters were sent via Federal Express on December 18, 2008 with return receipt to Stryker branches, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter stated the issue, the potential hazards, and the risk mitigation factors. The firm asked customers to examine their inventory and hospital locations to identify affected product; retrieve all affected product and return it to their branch or agency warehouse for reconciliation; reconcile all products on the attached Product Accountability Form; and return affected product. Questions should be directed to Karen Ariemma at 201-831-5718.
Quantity in Commerce 9 of lot code LBD528; 14 of lot code LBD512
Distribution Nationwide Distribution: FL and IL.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = HOWMEDICA OSTEONICS CORP
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