Recall archive / FDA device enforcement
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size... — FDA record Z-1237-2022
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 Mar 30, 2022. 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 Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
- Reason
- Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.
- Classification
- Class II
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 22 units (12 US; 10 OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1237-2022
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 | Catalog Number UDI-DI (GTIN) Lots 5536-B-600 07613327041514 CTD69463 5536-B-500 07613327041507 CTD69106 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide in the states of AL, CA, CO, ID, IN, KS, MI, NV, PA, TN, WA, and WV. The countries of UK and Poland.
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
- Jun 15, 2022
- Recall initiation date
- Mar 30, 2022
- Center classification date
- Jun 3, 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.