FDA recall Z-0139-2023

Wright Medical Technology, Inc. · Class II · device

Product

Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3

Reason for recall

The tibial tray lock detail is oversized (larger than specification).

Distribution

US Nationwide distribution in the state of New York.

Key facts

Status
Ongoing
Initiation date
2022-09-30
Report date
2022-11-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0139-2023