FDA Device recall Z-1215-2024
USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213…
- FDA Device
- Class II
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class II recall of USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213… 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-1215-2024 |
| 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 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,
Reason
Their is a potential that the implant curved stem may be oriented incorrectly.
Identifiers
| code_info | UDI(s): 04719872153894, 04719872153924, 04719872153863, 04719872153870, 04719872149866, 04719872153900, 04719872153917,…UDI(s): 04719872153894, 04719872153924, 04719872153863, 04719872153870, 04719872149866, 04719872153900, 04719872153917, 04719872153887 Lot Number(s): 15E198AA 15E198AA12 15E198AA22 15E198AA23 15E198S11 15E198S12 15E198W11 15E198W111 15E198X 15E198X21 15E198Y 15E198Y11 15E198Z 15E198Z111 15E198Z22 15E198Z3 16C168H 16C168H21 16C168H3 16C168J 16C168R1 17H618E 17H618E1 17H618E2 18A004A 18A004B 18A004B111 18A004C2 18A004C31 18A004D 18A004D1 18A004D21 18A004D22 18A004E 18A004E1 18A004E112 18A004F 18A004F111 18A004F211 18A004F212 18A004G 18A004G1 18A004G111 18A004G2 18A004G31 18A004H 18A004H212 18A004W11 20G378F2 20H134A 20H134A11 20H134A3 20H134B2 21D124A 21D124A1 21D124A2 21D124C1 21D124C11 21D512C 21D512C1 21D512C11 21D512D 21D512D2 21D512E2 21D512E3 21D512F1 21G420E1 21G420K1 21G420K11 21G420M1 21G420M2 21H573H1 21M254A 21M254B 21M254B1 21M254K 21M254X 21M254Y 21M254Y2 21M254Z 22F087AG 22F087AH 22F087AH1 22F087AJ 22F087AJ1 22K035C 22M166H 22M166J 22M166K 22M166K1 23A240C 23A240E 23A240E1 |
|---|
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-1215-2024%22
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