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U.S. Department of Health and Human Services

Class 2 Device Recall TRIATHLON TS KNEE SYSTEM

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 Class 2 Recall
TRIATHLON TS KNEE SYSTEM
see related information
Date Posted February 01, 2010
Recall Status1 Terminated on August 28, 2012
Recall Number Z-0758-2010
Recall Event ID 54138
Premarket Notification
510(K) Number
K070095 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made in the USA Stryker Orthopaedics, Mahwah, NJ 07430. The Triathlon Total Knee System components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function.
Code Information Catalog number: 5512-F-301; Lot coded: XKYG, XKYH, YBTHR1 and YEUAR1.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
For Additional Information Contact Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall
Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action An "Urgent Product Recall" Letter dated December 10, 2009 was sent by Federal Express to all Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. The letter described the affected product, issue and potential hazards. Consignees were instructed to complete Product Recall Acknowledgement Form and return to Stryker Orthopaedics via fax at 1-201-831-6069. All questions regarding the recall should be directed to Stryker Orthopaedics at 1-201-972-2100.
Quantity in Commerce 16
Distribution Worldwide Distribution -- United States (DE, NC, OH. MI, TX, CA, MA, NJ, TN, KS, GA, FL, AL, IN, MN, MD, NE, AR, OK, CO, AZ, OR, and MA), Australia, United Kingdom 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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