FDA-Device2022-01-12Class II
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). Catalog# 6541-9-109
Howmedica Osteonics Corp.
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
Sold states
US Nationwide distribution in the states of GA, MI, NC, TX.
Affected count
7 units
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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). Catalog# 6541-9-109
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0459-2022Don't want to check this manually?
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