FDA recall, , Moderate risk
Howmedica Osteonics Tri TS Baseplate
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
Summary by Recall Canary from the FDA notice
What happened
Howmedica Osteonics Corp. of Mahwah, New Jersey, began a recall on May 19, 2026, for Tri TS Baseplate Size 3 and Tri TS Baseplate Size 4, each in quantities of 7 units, because packaging labeled as one size contained the other size. The FDA added the recall to its Enforcement Report on June 17, 2026, and it was classified on the same date. Distribution was in Arizona, California, Georgia, Michigan, North Carolina, New Jersey, New York, and West Virginia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI, lot code and part code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
TRI TS Baseplate Size 3.
- UDI-DI
- 07613327026313
- Part code
- 5521-B-300.
- Lot code
- UZD9IB
TRI TS Baseplate Size 4.
- UDI-DI
- 07613327026061
- Part code
- 5521-B-400.
- Lot code
- TYX7OB
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Arizona, California, Georgia, Michigan, North Carolina, New Jersey, New York, West Virginia.
- Company
- Howmedica Osteonics Corp.Mahwah, New Jersey
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99080
- Recall numbers
- Z-2461-2026 to Z-2462-2026
All recalls from Howmedica Osteonics Corp.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
