Terminated

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.

FDA Recall Z-2158-2008 · Posted 2008-08-23

Recalling FirmStryker Howmedica Osteonics Corp.

Recall StatusTerminated

Product CodeHWT

Date Initiated2008-05-14

Date Terminated2010-01-26

Product QuantityCatalog 5566 T-009 to 025: 2625 US, 239 international

Reason for Recall

Triathlon TS Stems Trails may crack, potentially causing fragments of the plastic handle to fragment and break off completely.

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution --- including USA and countries of Australia, Canada, Sweden, Germany, Spain, Portugal, United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.