CLASS II ONGOING Device recall · Reported 21 May 2025 · FDA Enforcement Report
Perc Pin Adaptor recalled by Augmedics
Augmedics is recalling Perc Pin Adaptor, distributed nationwide in the US. The recall was initiated on 14 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1761-2025
- FDA event ID
- 96686
- Recalling firm
- Augmedics, Yokneam Illit Northern
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Apr 2025
- FDA classified
- 13 May 2025
- Reported
- 21 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 14 Apr 2025 | Recall initiated by company | |
| 13 May 2025 | Classified by FDA | +29 days |
| 21 May 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
Which lots are affected?
UDI: 07290113780910; Lot Numbers: 038110 to 054926
Where was it sold?
US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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