FDA recall Z-2461-2026

Howmedica Osteonics Corp. · Class II · device

Product

TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.

Reason for recall

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).

Distribution

US Nationwide distribution in the states of AZ, CA, GA, MI, NC, NJ, NY, WV.

Key facts

Status
Ongoing
Initiation date
2026-05-19
Report date
2026-06-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2461-2026