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Health product recall

Locator Implant Attachment (2014-01-16)

Starting date:
January 16, 2014
Posting date:
April 4, 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-38813

Recalled Products

Locator Implant Attachment

Reason

Products affected are currently provided with a label that indicates that the final torque applied to the abutment to prevent screw loosening should be 30 N-CM. To prevent abutment screw fractures the abutment torque value should be reduced to 20 N-CM.

Affected products

Locator Implant Attachment

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

Multiple

Companies
Manufacturer
Zest Anchors, LLC
also trading as Zest Anchors Inc. and Zest Anchors
2061 Wineridge Place
Escondido
92029
California
UNITED STATES