Recall Z-2539-2018— Ad-Tech Medical Instrument Corporation

Name: FDA recall Z-2539-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-02

Class II · Terminated

Class II FDA medical device recall by Ad-Tech Medical Instrument Corporation, initiated 2018-05-02, terminated 2019-02-08. It names one FDA 510(k) clearance: K170442. 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..

Recalling firm: Ad-Tech Medical Instrument Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-05-02
Terminated: 2019-02-08
Firm location: Oak Creek, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K170442 — Cranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation·cleared 2017-09-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.