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Osseocare Pro (2013-10-24)
- Starting date:
- October 24, 2013
- Posting date:
- December 4, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-37005
Recalled products
A. Osseocare Pro CA 20:1 L MS KM
Reason
When using the Osseocare Pro Ipad application release 1.2.0.7, the grey button located on the foot pedal has no effect on the rotation direction. Pressing the grey button normally sets the motor in reverse rotation mode. However, when pressing the grey button with the software release 1.2.0.7, this does not change the rotation direction. This malfunction may result in the screw tap and/or implant being placed deeper than intended, which in the worst case could damage vital anatomical structures (Mandibular nerve and blood vesseles, or penetration in to the Lumen of maxillary sinus or nasal cavity).
Affected products
A. Osseocare Pro CA 20:1 L MS KM
Lot or serial number
All lots
Model or catalog number
- 1700471
Companies
- Manufacturer
-
Bien-Air Dental SA
Langgasse 60
Bienne
2504
SWITZERLAND