FDA Medical devices recall ·
TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300 recall
- Recall number
- Z-2461-2026
- Date
- (initiated May 19, 2026)
- Company / brand
- Howmedica Osteonics Corp.
325 Corporate Dr, Mahwah, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
Why was it recalled?
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).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Part Number: 5521-B-300. UDI: (01)07613327026313(17)260921(10) UZD9IB. Lot Number: UZD9IB.
Distribution
US Nationwide distribution in the states of AZ, CA, GA, MI, NC, NJ, NY, WV.
States: Arizona California Georgia Michigan North Carolina New Jersey New York West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2461-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.