iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-00
FDA device recall Z-0227-2026 · posted 2025-10-21 · Open, Classified
Recall details
- Recalling firm
- Theken Companies LLC
- Reason for recall
- Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- MEH
- Quantity affected
- 409
- Distribution
- US Nationwide distribution in the states of NJ, PA, and TX.
- Date initiated
- 2025-09-11
- Date posted
- 2025-10-21
- Location
- Akron, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TheRay Collared and Collarless Femoral Stem (K241875) | Nextstep Arthropedix | 2024-09-13 |
| iNSitu Bipolar Hip System (K191297) | Theken Companies, LLC | 2019-09-17 |