RecallRadar

FDA Device recall Z-0110-2022

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

On 2021-10-20 the FDA classified a Class II recall of United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025 by Uoc Usa, citing due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0110-2022
ClassificationClass II
Statusterminated
Initiated2021-08-27
Published2021-10-20
Last updated2026-09-13 11:56 UTC
CompanyUoc Usa
DistributionUS

Product

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

Reason

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

Identifiers

code_infoCatalog Number: 2915-1025 UDI Code: 04719872148197 Lot Code: 19E272H

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0110-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.