Pilot and Twist Drills Stainless Steel (2016-11-22)

Starting date:

November 22, 2016

Posting date:

December 13, 2016

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-61414

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  Reason
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  Affected products

Affected Products

1. Pilot Drill - Stainless Steel
2. Twist - Drill Stainless Steel

Reason

The investigation of a complaint has confirmed that the shaft diameter of a drill (Article 044.215 Lot LV457) is greater than the defined specification of 2.35 mm in the area of the laser marking on the shaft. Further investigation has shown that additional articles and lots are impacted. Testing with different handpieces demonstrates that the drills can be inserted. However, depending on the manufacturing tolerances of the handpiece that is used, these drills may not fit. The drills are multiple use instruments and are delivered non-sterile. In accordance with instructions for use (IFU) 701124 they must be unpacked, disinfected, cleaned and sterilized before use. Additionally the IFU states that "before every use, the device has to be carefully checked for proper function and damage." If the drills do not fit into the handpiece and there is not an alternative instrument available, then the planned treatment will need to be re-scheduled.

Affected products