Recall Z-0110-2022— Uoc Usa Inc
Class II · Terminated
Class II FDA medical device recall by Uoc Usa Inc, initiated 2021-08-27, terminated 2023-01-20. It names one FDA 510(k) clearance: K190100. 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..
- Recalling firm
- Uoc Usa Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-08-27
- Terminated
- 2023-01-20
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.