United Orthopedics USTAR II Knee System USTAR II Knee recall
United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
Why was United Orthopedics USTAR II Knee System USTAR II Knee recalled?
Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: 2915-1025 UDI Code: 04719872148197 Lot Code: 19E272H
- Product
- United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
- Recalling firm
- Uoc Usa Inc
- Quantity
- 3 devices
- Distribution
- U.S. Nationwide: CA, CO, and NV No O.U.S.
- Recall date
- October 20, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)