—#71695

Product

Stem 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.

FDA product code: HWT — Template
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: All lot codes

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

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

Timeline

Recall initiated: 2008-05-14
Posted by FDA: 2008-08-23
Terminated: 2010-01-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71695. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.