FDAJune 23, 2016device
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. Th...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
stryker howmedica osteonicsstrykerstryker howmedica
Recall history
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