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Tapered Screw-Vent Implant (2014-10-09)

Starting date:
October 9, 2014
Posting date:
October 14, 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-41793

Recalled Products

Tapered Screw-Vent Implant

Reason

Zimmer Dental is conducting a recall of a single lot of the tapered screw-vent implant, catalog TSV4B11, because the inner vial could be potentially mislabelled as "04.1 x 10mml" instead of "04.1 x 11.5mml". The main label on the outside of the package, the outer vial label, the cap label, and the patient chart label contain the correct information regarding the implant within the package.

Affected products

Tapered Screw-Vent Implant

Lot or serial number

62658448

Model or catalog number

TSV4B11

Companies
Manufacturer
Zimmer Dental Inc.
1900 Aston Avenue,
Carlsbad,
92008
California
UNITED STATES