iNSitu Bipolar Hip System, Bipolar head implant recallZ-0227-2026 · Theken Companies LLC · initiated Sep 11, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Theken Companies LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
FDA root cause category: Package design/selection
What the company is doing
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.
Recall details
- Recall number
- Z-0227-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 11, 2025
- Posted by the FDA
- Oct 21, 2025
- Recalling firm
- Theken Companies LLC
- Quantity
- 409
- Product code
- MEH
- FDA submissions
- K191297, K241875
- Distribution
- US Nationwide distribution in the states of NJ, PA, and TX.
Product description
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
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
12 devices in the FDA device registry whose identifier appears in the recall's code information.
- InSitu Hip System 10-22-0038Nextstep Arthropedix, LLC · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1 recall0 reports
- InSitu Hip System 10-22-0040Nextstep Arthropedix, LLC · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1 recall0 reports
- InSitu Hip System 10-22-0042Nextstep Arthropedix, LLC · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1 recall0 reports
- InSitu Hip System 10-22-0044Nextstep Arthropedix, LLC · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1 recall0 reports
- InSitu Hip System 10-22-0046Nextstep Arthropedix, LLC · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1 recall0 reports
- InSitu Hip System 10-22-0048Nextstep Arthropedix, LLC · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1 recall0 reports
- InSitu Hip System 10-22-0050Nextstep Arthropedix, LLC · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1 recall0 reports
- InSitu Hip System 10-22-0052Nextstep Arthropedix, LLC · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1 recall0 reports
- InSitu Hip System 10-22-0054Nextstep Arthropedix, LLC · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1 recall0 reports
- InSitu Hip System 10-22-0056Nextstep Arthropedix, LLC · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1 recall0 reports
- InSitu Hip System 10-22-0058Nextstep Arthropedix, LLC · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1 recall0 reports
- InSitu Hip System 10-22-0060Nextstep Arthropedix, LLC · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1 recall0 reports
Other devices under the same FDA submission
2 devices cleared under K191297, K241875 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- TheRay Collared and Collarless Femoral Stem 12-10-0002Nextstep Arthropedix, LLC · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate1 report
- TheRay Collared and Collarless Femoral Stem 12-10-0006Nextstep Arthropedix, LLC · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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