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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96686

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 14, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Augmedics Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1761-2025
Recall number
Z-1761-2025
Initiated
April 14, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Augmedics Ltd.
Quantity
85 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI: 07290113780910; Lot Numbers: 038110 to 054926

Distribution pattern

US Nationwide.