Hip Implant Recall: Theken iNSitu Bipolar Head
Announced 2025-10-29 · FDA
The recall involves Theken Companies LLC iNSitu Bipolar Hip System, Bipolar Head Assembly implants in sizes 38 mm through 60 mm. It is a downstream recall for RES 97605 after the product failed transit testing and may have issues with the sterile barrier. About 409 units were distributed in New Jersey, Pennsylvania, and Texas, and all lots/serial numbers are affected.
| Brand | Theken Companies LLC |
|---|---|
| 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 | Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier. |
| Severity | moderate |
| Units affected | 409 |
| Distribution | US Nationwide distribution in the states of NJ, PA, and TX. |
| Agency | FDA |
| Recall / campaign no. | 10-22-0038 UDI-DI 00816127029431 Lots 2036, 2036-RP, 3495, 3495-1; 10-22-0040 UDI-DI 00816127029448 Lots 2037, 2037-RP, 3491, 3491-1; 10-22-0042 UDI-DI 00816127029455 Lot 2038-RP; 10-22-0044 UDI-DI 00816127029462 Lots 2039-RP, 3496-1; 10-22-0046 UDI-DI 00816127029479 Lots 2040, 2040-RP, 3492, 3492-1; 10-22-0048 UDI-DI 00816127029486 Lot 2041-RP; 10-22-0050 UDI-DI 00816127029493 Lots 2042, 2042-RP; 10-22-0052 UDI-DI 00816127029509 Lots 2043, 2043-RP; 10-22-0054 UDI-DI 00816127029516 Lots 2044, 2044-RP; 10-22-0056 UDI-DI 00816127029523 Lots 2045, 2045-RP; 10-22-0058 UDI-DI 00816127029530 Lots 2046, 2046-RP, 3493; 10-22-0060 UDI-DI 00816127029547 Lots 2047, 2047-RP, 3494 All lots/serial numbers |
WHAT YOU SHOULD DO
- Check if your implant matches the iNSitu Bipolar Head Assembly sizes 38-60 mm and review the listed lots/UDI numbers; contact your surgeon if it may be affected.
- Do not attempt to remove or modify the implant yourself; follow your healthcare provider's guidance.
- Schedule an evaluation with your surgeon if you have concerns or symptoms, and report any adverse experiences to your healthcare provider.
- Visit the FDA recall page for updates and additional instructions.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.