iNSitu Bipolar Hip System — Class II medical device recall Z-0227-2026
Ongoing recall by Theken Companies LLC, reported 2025-10-29, distributed nationwide. Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product m
| Recall number | Z-0227-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Theken Companies LLC, Akron, OH, United States |
| Recall initiated | 2025-09-11 |
| Classified | 2025-10-21 |
| Reported by FDA | 2025-10-29 |
| Distributed | Nationwide (US) |
| Quantity | 409 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00816127029431, 00816127029448, 00816127029455, 00816127029462, 00816127029479, 00816127029486, 00816127029493, 00816127029509, 00816127029516, 00816127029523, 00816127029530, 00816127029547 |
| Lot numbers | 10-22-0040, 10-22-0042, 10-22-0044, 10-22-0046, 10-22-0048, 10-22-0050, 10-22-0052, 10-22-0054, 10-22-0056, 10-22-0058, 10-22-0060, 2036, 2036-RP, 2037, 2037-RP, 2038-RP, 2039-RP, 2040, 2040-RP, 2041-RP, 2042, 2042-RP, 2043, 2043-RP, 2044, 2044-RP, 2045, 2045-RP, 2046, 2046-RP, 2047, 2047-RP, 3491, 3491-1, 3492, 3492-1, 3493, 3494, 3495, 3495-1 and 1 more |
Product
iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm
Reason for recall
Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
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-0227-2026. 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.