Health product recall

Osscora Surgical Set (2018-02-14)

Starting date:
February 14, 2018
Posting date:
March 2, 2018
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-66084

Affected products

Osscora Surgical Set

Reason

The supplier W&H Dentalwerk (in Burmoos, Austria) notified Cochlear Bone Anchored Solutions (CBAS) of a potential malfunction in the foot control included in Osscora Surgical Set (part# 91053). Foot control may not switch back to zero position when pedal is released-causing motor to continue rotation. Drilling mode not affected. Automatic torque stop is fully functional.

Affected products

Osscora Surgical Set

Lot or serial number

E01039

Model or catalog number

91053

Companies
Manufacturer

Cochlear Bone Anchored Solutions Ab

Konstruktionsvagen 14

Molnlycke

43533

SWEDEN