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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80280

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

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Event summary

Timeline bucket
May 02, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ad-Tech Medical Instrument Corporation

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

AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement. The DSG-6.3-090-2.4N drill sleeve guides are intended to be used with the 2.4mm Cranial Drill Bit diameter.

Z-2539-2018
Recall number
Z-2539-2018
Initiated
May 02, 2018
Classification
Class II
Status
Terminated
Quantity
65 Total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.

Code information

Catalog Number DSG-6.3-090-2.4N. Batch Number (Lot Number): 107104 (710220), 114390 (715001), 111423 (716180), 105176 (613121), 113775 (719190), 115847 (712211), 113776 (719190), 115000 (714201), 114724 (711101), 116389 (712121), 117146 (810110).

Distribution pattern

US Nationwide distribution in the states of CA, FL, IL, MI, NH, NY, OH, OR, PA, SC, UT, WV. Worldwide distribution to Canada, Denmark, Germany, India, Israel, Japan, Russia, South Korea, Taiwan, United Kingdom.