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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon TS Femoral Trial

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  Class 2 Device Recall Triathlon TS Femoral Trial see related information
Date Initiated by Firm March 05, 2008
Date Posted July 26, 2008
Recall Status1 Terminated 3 on October 25, 2010
Recall Number Z-1573-2008
Recall Event ID 47400
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Triathlon TS Femoral Trial;
Size 1 Right
Non-Sterile
Catalog number: 5512-T-102

Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430

Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
Code Information Lot Code WFLI
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Rita Intorella
201-831-5825
Manufacturer Reason
for Recall		 Sharp edges will cause a glove to tear and cut someone. Sharp edges on the slots machines in select lots of the Triathlon TS Femoral Trials, sizes 1-8, have been discovered.
FDA Determined
Cause 2		 Process control
Action Stryker Branches/Agencies were notifed by letter (Urgent Product Recall) on March 5, 2008. Reps were asked to examine inventory and visit hospitals that were provided with the device to retrieve product. Reps were instructed to retrieve all of the affected product lots and return them to their branch or agency warehouse for reconciliation. All products should be reconcilied on the Product Accountability Form that is attached to the letter and sent via Inter-Org Transfer back to Stryker Orthopaedics. Questions and re-orders of the product that is being returned should be directed to 201-831-5825.
Quantity in Commerce 3
Distribution Nationwide Distribution --- including states of CT, NJ, PA, VA, NC, GA, FL, AL, MI, MN, IL, TX and AZ.
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.
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