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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 Instrumentssee related information
Date Initiated by FirmMay 14, 2008
Date PostedAugust 23, 2008
Recall Status1 Terminated 3 on January 26, 2010
Recall NumberZ-2157-2008
Recall Event ID 48596
Product Classification Template - Product Code HWT
ProductStem Trial, Triathlon Revision Instruments; Non-Sterile; 100 mm length Catalog numbers: 5565-T-009, 5565-T-010, 5565-T-011, 5565-T-012, 5565-T-013, 5565-T-014 5565-T-015, 5565-T-016, 5565-T-017, 5565-T-018, 5565-T-019, 5565-T-020 5565-T-021, 5565-T-022, 5565-T-023, 5565-T-024, 5565-T-025 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Used in Revision TKA.
Code Information All lot codes
FEI Number 3003070421
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information ContactRita Intorella
201-831-5000
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
ActionUrgent 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 CommerceCatalog Number 5565 T-009 to 025: 2629 US, 238 international: Catalog 5566 T-009 to 025: 2625 US, 239 international
DistributionWorldwide Distribution --- including USA and countries of Australia, Canada, Sweden, Germany, Spain, Portugal, United Kingdom.
Total Product Life CycleTPLC 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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