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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon

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  Class 2 Device Recall Triathlon see related information
Date Initiated by Firm December 04, 2006
Date Posting Updated February 08, 2007
Recall Status1 Terminated 3 on February 21, 2007
Recall Number Z-0399-2007
Recall Event ID 37024
510(K)Number K051146  
Product Classification knee prosthesis component - Product Code JWH
Product Triathlon X3 CR Tibial Bearing Insert
for knee prosthesis
Size #2 - 11MM
Ref # 5530-G-211

Howmedica Osteonics Corp.
Code Information Ref. No. 5530-G-211, Lot code G9XF6, LAF974
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Larry Ross
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
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 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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = HOWMEDICA OSTEONICS CORP