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Health product recall

ZIMMER DENTAL GEMLOCK 2.5MM HEX DRIVER (2017-10-18)

Starting date:
October 18, 2017
Posting date:
October 27, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-64976

Affected products

ZIMMER DENTAL GEMLOCK 2.5MM HEX DRIVER

Reason

Zimmer Biomet Dental is conducting a medical device recall for the GemLock 2.5mm Hex Driver because it may contain a manufacturing condition affecting the geometry of the driver's hex feature, which prevents it from properly mating components. The RHD2.5 Hex Driver is distributed individually as well as in instrument kits, such as the Tapered Screw-Vent Implant Surgical System Kit (catalog TSVKIT).

Affected products

ZIMMER DENTAL GEMLOCK 2.5MM HEX DRIVER

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • RHD2.5
  • TSVKIT
Companies
Manufacturer
Zimmer Dental Inc.
1900 Aston Avenue
Carlsbad
92008
California
UNITED STATES