AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677)…

Date

Aug. 1, 2018

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 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.

Reason

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.

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.

Quantity

65 Total

Codes and lots

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).

Recall started

May 2, 2018

Device type

Drills, Burrs, Trephines & Accessories (Simple, Powered)

Root cause (FDA)

Nonconforming Material/Component

What the company told customers

Customers were notified on 05/02/2018 via a MEDICAL DEVICE RECALL letter. Instructions included to immediately examine your inventory and quarantine any product subject to recall and replacement. Customers/distributors who received affected devices will be contacted to return their unopened/unused and/or reused stock of the affected product.

Recall number

Z-2539-2018

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

Source: FDA · Medical device enforcement report, recall number Z-2539-2018. The agency record governs; check it and the company before acting.