Z-2544-2019Class II

AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N

Name: Z-2544-2019 AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
Creator: Ad-Tech Medical Instrument Corporation
Published: 2019-08-27
License: https://open.fda.gov/license/

AD-Tech Medical Instrument Corp. / initiated 2019-08-27 / Terminated

FDA source

Ad-Tech Medical Instrument Corporation began a recall of AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N on 2019-08-27. FDA classified it as Class II and gives the reason as "The inner 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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2544-2019
Classification: Class II
Status: Terminated
Initiated: 2019-08-27
Posted: 2019-09-13
Terminated: 2023-04-05
Recalling firm: AD-Tech Medical Instrument Corp.
Product: AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
Product code: HBG Drills, Burrs, Trephines & Accessories (Manual)
Reason for recall: The inner 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.
FDA root cause: Under Investigation by firm
Action: The firm initiated the recall by letter on 08/27/2019. The firm requested the units be returned.
Quantity in commerce: 315 units
Distribution: NY, PA, WI, AZ, IL, CA, NH, GA, MA, MN, UT, MI, WA, FL, TX, OH, OR, PA, MD, and India, Korea, Taiwan, Canada, Hong Kong, Denmark, Russia, Singapore, Japan, Brazil. UK, Spain, Czech Republic, France
Product codes and lots: All serial numbers distributed between January 2014 and May 2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2544-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2544-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-25	2019-09-13

Product code HBG

K170442Class IICranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation / cleared 2017-09-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)