Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Stryker Orthopaedics Modular Handle Triathlon Instruments Recalled by Stryker Howmedica Osteonics Corp. Due to Stryker Orthopaedic is voluntarily recalling the Triathlon Modular...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Howmedica Osteonics Corp. directly.
Affected Products
Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Product Usage: Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee Replacement (PKR) system. The use of the handles in Primary TKA is optional and may be used to: (1) Assist in stabilizing the Triathlon Femoral Sizer, (2) Aid in stabilization during use and removal of the Triathlon 4:1 Cutting Block and (3) Aid in assembly of the Anterior MIS Distal Resection Guide to the Anterior Skim Cut Guide. Per the Triathlon PKR surgical protocol, the handle is required for a PKR surgery and is used to: (1) Assemble and disassemble the Femoral Trial Drill Guide into the Femoral Trial and (2) Remove the Peg Trial from the Femoral Trial.
Quantity: 12,469 units
Why Was This Recalled?
Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved potentially resulting in disassociation from the instrument.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics Corp. has 87 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report