Drill Sleeve Guide (2019-08-22)

Starting date:

August 22, 2019

Posting date:

October 11, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71255

Last updated: 2019-10-11

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  Reason
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  Affected products

Affected Products

Drill Sleeve Guide

Reason

On August 22, 2019, Ad-Tech Medical Instrument Corporation decided to voluntarily recall all drill sleeve guides which are intended to be used only with the 2.4mm diameter cranial drill bit. This recall has been initiated due to an investigation being performed that has identified potential issues with both of our raw material suppliers.

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. Although these devices do not make patient contact and are not expected to result in death, this issue could result in a delay in procedure.

Affected products