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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 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
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
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 = LXH and Original Applicant = STRYKER ORTHOPAEDICS
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