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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon

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 Class 2 Recall
Triathlon
see related information
Date Posted February 08, 2007
Recall Status1 Terminated on February 21, 2007
Recall Number Z-0399-2007
Recall Event ID 37024
Premarket Notification
510(K) Number
K051146 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #2 - 11MM Ref # 5530-G-211 2011-09 Howmedica Osteonics Corp.
Code Information Ref. No. 5530-G-211 Lot code G9XF6 LAF974
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Larry Ross
201-831-5972
Manufacturer Reason
for Recall
A product mix-up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and vice versa.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Notification letters and Product Accountability forms were sent on 12/8/2006 by Federal Express with return receipt.
Quantity in Commerce 23 units
Distribution Nationwide and Canada.
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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