Theken Companies LLC: 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 Hea

Hazard

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

Details from the source

Reason for recall: Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier. Distribution: US Nationwide distribution in the states of NJ, PA, and TX. Quantity: 409 Lot/code info: 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

UPC codes

00816127029431, 00816127029448, 00816127029455, 00816127029462, 00816127029479, 00816127029486, 00816127029493, 00816127029509, 00816127029516, 00816127029523, 00816127029530, 00816127029547

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.