Use cautionMedical device recall · FDA · Published November 24, 2021
Howmedica O: Triathlon Pro Tibial Tray Recall - Wrong Keel Punch Risk
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
Take action
Contact the company
📍Recalling firmHowmedica Osteonics Corp.325 Corporate Dr · Mahwah, NJ 07430-2006
“Howmedica O: Triathlon Pro Tibial Tray Recall - Wrong Keel Punch Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61501-howmedica-o-triathlon-pro-tibial-tray-recall-wrong-keel-punch. Based on FDA recall #Z-0459-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0459-2022%22&limit=1).
The FDA announced on November 24, 2021, that Howmedica Osteonics Corp. is recalling Triathlon Pro Tibial Preparation Tray kits because they may contain the wrong keel punch instrument. The agency said the error could lead to surgery delays or unintended bone preparation. Owners should contact the company for a remedy.
How to tell if you have it
Brand: Howmedica Osteonics
Product: Triathlon Pro Tibial Preparation Tray, Revision AC-
Catalog #: 6541-9-109
Lots #: 0552101A596, 0552101A602
GTIN#: 07613327461503
UPC: 07613327461503
Distribution: US Nationwide, including GA, MI, NC, TX
The hazard
The 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 correct Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y). According to the FDA, this error can lead to delay in surgery or, if used, could lead to unintended bone preparation.
Context
GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since July 21, 2017. Recent brand recalls include the OMNIFIT Series I Acetabular Insert Recall dated July 30, 2026, and the Triathlon Baseplate Size 3 Recall dated May 19, 2026. Other recent recalls of similar products include the Encore Medical EMPOWR 3D Knee Tibial Insert 5R 14MM Recall (Jan. 5, 2026), the Encore Medical EMPOWR 3D KNEE Ins 11L 14MM VE Recall (Feb. 16, 2026), and the EMPOWR 3D KNEE Implants Have Incorrect Labeling - Recall Notice (Jan. 15, 2026).
How to tell if you have this one
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.
Brand
Howmedica Osteonics
Product
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Tray Details
Look for catalog number 6541-9-109 and lot numbers 0552101A596 or 0552101A602 on the tray.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of GA, MI, NC, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Georgia, Michigan, North Carolina, Texas.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0459-2022 (November 24, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0459-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.