FDA recall Z-0110-2022

Product

United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025

Reason for recall

Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.

Distribution

U.S. Nationwide: CA, CO, and NV No O.U.S.

Key facts

Status

Terminated

Initiation date

2021-08-27

Report date

2021-10-20

Termination date

2023-01-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0110-2022