AD-TECH Drill Sleeve Guides…

Date

Sept. 25, 2019

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Ad-Tech Medical Instrument Corporation

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

Reason

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.

Distribution pattern

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

Quantity

315 units

Codes and lots

All serial numbers distributed between January 2014 and May 2019

Recall started

Aug. 27, 2019

Device type

Drills, Burrs, Trephines & Accessories (Manual)

Root cause (FDA)

Under Investigation by firm

What the company told customers

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

Recall number

Z-2544-2019

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2544-2019. The agency record governs; check it and the company before acting.