Howmedica Osteonics Corp.: Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Recall Summary Stryker has recalled Triathlon Universal Baseplate Size 3 knee implants because some units were packaged with incorrect labeling—Size 3 implants were labeled as Size 4 and vice versa. This mislabeling could result in surgeons implanting the wrong size component during knee replacement surgery. The affected products were distributed nationwide to hospitals and surgical centers.
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
- Reason
- 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).
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-19
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of AZ, CA, GA, MI, NC, NJ, NY, WV.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/2323626a-eab1-44d1-b164-a4d850bbedf3