Recall Z-0227-2026 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
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 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
| Date | Oct 21, 2025 (initiated Sep 11, 2025) |
| Status | Open, Classified |
| Reason | Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier. |
| Root cause | Package design/selection |
| Action | 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. |
| Quantity | 409 |
| Distribution | US Nationwide distribution in the states of NJ, PA, and TX. |
| FDA record | Open on fda.gov |