Recall archive / FDA device enforcement
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for steri... — FDA record Z-0459-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 24, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- 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
- Classification
- Class II
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 7 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0459-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lots #: 0552101A596, 0552101A602 GTIN#: 07613327461503 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of GA, MI, NC, TX.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 12, 2022
- Recall initiation date
- Nov 24, 2021
- Center classification date
- Jan 6, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.