Howmedica Osteonics recalls Triathlon Pro Tibial Preparation Tray Revision AC- for possible wrong keel punch causing surgery delays or unintended bone damage. Affected units sold with specific catalog and lot numbers.
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
Howmedica Osteonics is recalling Triathlon Pro Tibial Preparation Trays (Revision AC-) that may have been kitted with the wrong keel punch. This could delay surgery or cause unintended bone preparation during knee replacement procedures.
The tray may have been assembled with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the correct Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y). This mismatch could delay surgery or cause unintended bone preparation during the procedure.
Patients undergoing total knee replacement surgery who use this specific tray model. Surgeons and surgical teams are most at risk due to potential delays or complications during the procedure.
Check for catalog number 6541-9-109 and lot numbers 0552101A596 or 0552101A602 on the tray. The product is used for sterilizing reusable instruments in total knee replacement surgeries.
Look for catalog number 6541-9-109 and lot numbers 0552101A596 or 0552101A602 on the tray.
Using the recalled tray with the wrong keel punch could delay surgery or cause unintended bone preparation during knee replacement procedures.
Check for catalog number 6541-9-109 and lot numbers 0552101A596 or 0552101A602 on the tray.
The recall does not specify a remedy, so no action is required beyond checking if the tray has the recalled lot numbers.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-0459-2022 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-0459-2022 from Howmedica Osteonics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
