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Health product recall

CGS3000 GUIDED SURGERY KIT (2015-06-01)

Starting date:
June 1, 2015
Posting date:
June 26, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Identification number:
RA-53930

Recalled Product

A.CGS3000 GUIDED SURGERY KIT

Reason

Manufacturer determined that the CGS-3000 Guided Surgery Kit was assembled using two (2) CGS-PBIDHS CGS Implant-Level Driver Handpiece, 5.8mm, short, instruments instead of one (1) each CGS-PBIDHS and one (1) CGS-PGIDHS CGS Implant-Level Driver Handpiece, 4.6mm, short, in position #52.

Affected products

A.CGS3000 GUIDED SURGERY KIT

Lot or serial number

1502795

Model or catalog number

CGS3000

Companies
Manufacturer
BioHorizons Implant Systems, Inc.
2300 Riverchase Center
Birmingham, Alabama
35244
UNITED STATES