Augmedics Perc Pin Adaptor — Class II medical device recall Z-1761-2025
Ongoing recall by Augmedics Ltd., reported 2025-05-21, distributed nationwide. The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening mar
| Recall number | Z-1761-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Augmedics Ltd., Yokneam Illit Northern, Israel |
| Recall initiated | 2025-04-14 |
| Classified | 2025-05-13 |
| Reported by FDA | 2025-05-21 |
| Distributed | Nationwide (US) |
| Quantity | 85 units |
| UPC / GTIN / UDI-DI | 07290113780910 |
| Lot numbers | 038110, 054926 |
| Model numbers | AMCH07200 |
Product
Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery.
Reason for recall
The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1761-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.