FDA Device recall Z-1761-2025
Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation syste…
- FDA Device
- Class II
- ongoing
- Published 2025-05-21
On 2025-05-21 the FDA classified a Class II recall of Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation syste… by Augmedics, citing the perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1761-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-14 |
| Published | 2025-05-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Augmedics |
| Distribution | US |
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
The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
Identifiers
| code_info | UDI: 07290113780910; Lot Numbers: 038110 to 054926 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1761-2025%22
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