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U.S. Department of Health and Human Services

Class 2 Device Recall Stem Trial, Triathlon Revision Instruments

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  Class 2 Device Recall Stem Trial, Triathlon Revision Instruments see related information
Date Initiated by Firm May 14, 2008
Date Posted August 23, 2008
Recall Status1 Terminated 3 on January 26, 2010
Recall Number Z-2158-2008
Recall Event ID 48596
Product Classification Template - Product Code HWT
Product Stem Trial, Triathlon Revision Instruments; Non-Sterile; 150 mm length
Catalog Numbers:
5566-T-009, 5566-T-010, 5566-T-011, 5566-T-012, 5566-T-013, 5566-T-014
5566-T-015, 5566-T-016, 5566-T-017, 5566-T-018, 5566-T-019, 5566-T-020
5566-T-021, 5566-T-022, 5566-T-023, 5566-T-024, 5566-T-025

Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430

Used in Revision TKA.
Code Information All Lot Codes 
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Rita Intorella
Manufacturer Reason
for Recall
Triathlon TS Stems Trails may crack, potentially causing fragments of the plastic handle to fragment and break off completely.
FDA Determined
Cause 2
Process control
Action Urgent Product Recall notification letters were sent to all Stryker Branch/Agency Manager/Quality contacts on May 14, 2008 via Federal Express. The letter requests that consignees examine their inventory and hospital consignment locations to identify the product; and retrieve all affected product lots and return it to their branch or agency warehouse for reconciliation. The letter also states that a Stryker Orthopaedics Customer Service rep should be contacted for alternative products available.
Quantity in Commerce Catalog 5566 T-009 to 025: 2625 US, 239 international
Distribution Worldwide Distribution --- including USA and countries of Australia, Canada, Sweden, Germany, Spain, Portugal, United Kingdom.
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.