Recall Z-1215-2024 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
United Orthopedic Corporation
USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm, PE11151411 - 11x200mm, PE11151413 - 13x200mm, PE11151415 - 15x200mm, PE11151417 - 17x200mm,
| Date | Feb 29, 2024 (initiated Jan 3, 2024) |
| Status | Open, Classified |
| Reason | Their is a potential that the implant curved stem may be oriented incorrectly. |
| Root cause | Nonconforming Material/Component |
| Action | On 1/18/24, United Orthopedic contacted consignees via phone to make them aware of the Urgent: Medical Device Recall that was being initiated. United Orthopedic also issued a Urgent: Medical Device Recall notification to affected consignees. United Orthopedic asked consignees to take the following actions: 1. Please examine your inventory immediately to locate the affected product whose quantities and lot numbers are listed above. 2. Please cease all use of these devices immediately and quarantine all affected devices in your territory for immediate return. 3. Customer Service will be con |
| Quantity | 598 units |
| Distribution | US: CA,KY, MI, IN, TN, CO, FL, TX, NV, OUS: Switzerland, United Kingdom, Malaysia, Philippines, Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190100 | USTAR II System United Orthopedic Corporation, Sep 23, 2019 |