FDANovember 24, 2021device
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee arthroplasty (TKA). Catalo...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation
What to do
FDA enforcement status: Ongoing
Brands named
howmedica osteonicshowmedica
UPCs
07613327461503
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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