FDA Device recall Z-1216-2024
USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x1…
- FDA Device
- Class II
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class II recall of USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x1… by United Orthopedic, citing their is a potential that the implant curved stem may be oriented incorrectly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1216-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-03 |
| Published | 2024-03-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | United Orthopedic |
| Distribution | CA, CO, FL, IN, KY, MI, NV, TN, TX |
Product
USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153115 - 15x125mm, PE25153211 - 11x150mm, PE25153213 - 13x150mm, PE25153217 - 17x150mm, PE25153117 - 17x125mm, PE25153015 - 15x100mm, PE25153215 - 15x150mm
Reason
Their is a potential that the implant curved stem may be oriented incorrectly.
Identifiers
| code_info | UDI(s): 04711605584562 04711605584579 04711605584586 04711605584616 04711605584630 04719872149866 04719872153542 047198…UDI(s): 04711605584562 04711605584579 04711605584586 04711605584616 04711605584630 04719872149866 04719872153542 04719872153559 04719872153566 04719872153573 04719872153610 04719872153658 04719872153665 04719872153672 04719872153689 04719872153696 04719872153863 04719872153870 04719872153887 04719872153894 04719872153900 04719872153917 04719872153924 04719872154341 04719872154358 04719872154365 04719872154372 04719872154389 04719872154396 04719872154402 04719872154419 Lot Number(s): 15E198AA 15E198S11 15E198Y 15E198Z 15E198Z111 16C168H 16C168H3 16C168J 16F306B2 16F306C 16F306C1 16F306E121 16H278K1 16H278K111 16H278K3 16H278L1 16H278L31 16H278N2 16H280D1 16H280D31 16H280D4 16H280E1 16H280E11 16H280E3 16H280F11 17B448AY13 17H618E1 18A004B 18A004C2 18A004D 18A004D1 18A004F 18A004G 18A004G1 18A004W11 18C255FG 18C255FG11 18C255FG12 18C255K31 18C255R 18C255W11 18C255X 18C255X1 18C255Y131 18C256A122 19G738DN 19G738DN12 19G738DN3 19G738DP 19G738DQ 19G738DR12 19G738DW12 19K248AR 19K248AS 19L4 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1216-2024%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.