iNSitu Bipolar Hip System (Theken) – Sterile Barrier Risk (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Theken Companies LLC
Lot Codes / Batch Numbers
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
Products Sold
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
Theken Companies LLC is recalling iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Asse due to Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile ba. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
Recommended Action
Per FDA guidance
NextStep Arthropedix contacted their distributors via phone on September 11-12, 2025, to notify them of the situation. The distributors were instructed to quarantine and return all Bipolar Head implants. A formal recall letter with instructions for returning the inventory to NextStep Arthropedix was sent to customers on September 19, 2025.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026