Recall Z-0110-2022 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Uoc Usa Inc
United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
| Date | Aug 27, 2021 |
| Status | Terminated |
| Reason | Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing. |
| Root cause | Device Design |
| Action | On 08/27/2021, the Recalling Firm communicated via email a letter to customers/US surgeons informing them that they are initiating a product recall limited to its 25 mm segment from its knee system due to an out of specification condition that has the potential to pose a risk to patients. Customers are instructed to return unused products. For questions, contact the Director of Customer Service at 949-328-3366 or the Vice President of Marketing at 949-501-8575. On 09/16/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" notification letter to additional customers, who have not used or r |
| Quantity | 3 devices |
| Distribution | U.S. Nationwide: CA, CO, and NV No O.U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190100 | USTAR II System United Orthopedic Corporation, Sep 23, 2019 |