Theken Companies LLC: Medical Device Recall in 2025 - (Recall #: Z-0227-2026)

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

Class II

Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

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

US Nationwide distribution in the states of NJ, PA, and TX.

Voluntary: Firm initiated