USTAR II Knee System Cemented curved stem — Class II medical device recall Z-1216-2024
Ongoing recall by United Orthopedic Corporation, reported 2024-03-06, distributed in CA, CO, FL, IN, KY, MI, NV, TN…. Their is a potential that the implant curved stem may be oriented incorrectly.
| Recall number | Z-1216-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | United Orthopedic Corporation, Hsinchu, Taiwan |
| Recall initiated | 2024-01-03 |
| Classified | 2024-02-29 |
| Reported by FDA | 2024-03-06 |
| Distributed | CA, CO, FL, IN, KY, MI, NV, TN, TX |
| Countries outside the US | CH, GB, MY, PH, TW |
| Quantity | 479 units |
| UPC / GTIN / UDI-DI | 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 and 6 more |
| Lot numbers | 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 and 88 more |
| Model numbers | 11X125MM, 11X150MM, 13X125MM, 13X150MM, 15X100MM, 15X125MM, 15X150MM, 17X125MM, 17X150MM, 9X125MM, 9X150MM, PE25153015, PE25153109, PE25153111, PE25153113, PE25153115, PE25153117, PE25153209, PE25153211, PE25153213, PE25153215, PE25153217 |
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 for recall
Their is a potential that the implant curved stem may be oriented incorrectly.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1216-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.