Open, Classified

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

FDA Recall Z-0227-2026 · Posted 2025-10-21

Recall StatusOpen, Classified

Product CodeMEH

Date Initiated2025-09-11

Product Quantity409

Reason for Recall

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

Firm 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.

Root Cause

Package design/selection

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix · 2024-09-13 K191297iNSitu Bipolar Hip SystemTheken Companies, LLC · 2019-09-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.