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MI1000 Pin Drill (2014-03-24)
- Starting date:
- March 24, 2014
- Posting date:
- April 30, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-39215
Recalled products
- MI1000 Pin Drill
Reason
Potential hazard can occur with the MI1000 pin drill guide after repeated use and if wear is undetected. Med-El has determined that the MI1000 pin drills must no longer be used during cochlear implant surgery in the ENT clinic to prevent any harm arising from undetected wear. These drills do not fit standard noth american drill tools. However, should use of these drills be possible, a risk may exist.
Affected products
A. MI1000 Pin Drill
Lot or serial number
All lots
Model or catalog number
- 07756
- 07758
Companies
- Manufacturer
-
Med-El Elektromedizinische Geraete GmbH
Fuerstenweg 77A
Innsbruck
6020
AUSTRIA