FDA Device

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

Hazard

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.

What You Should Do

Remedy

The firm initiated the recall by letter on 08/27/2019. The firm requested the units be returned.

Products

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
Brand
Ad-Tech Medical Instrument Corporation
UPC
All serial numbers distributed between January 2014 and May 2019

Units Affected

315 units