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Health product recall

Guided Handle Kit (2017-05-05)

Starting date:
May 5, 2017
Posting date:
September 26, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-64576

Affected products

Guided Handle Kit

Reason

The 2.3 guide insert is too small, not allowing the 2.3 drill to pass through. The 3.4 insert is the same diameter as the 2.3 insert.

Affected products

Guided Handle Kit

Lot or serial number

65249

Model or catalog number

G-HK

Companies
Manufacturer
Implant Direct Sybron Manufacturing LLC
3050 East Hillcrest Drive
Thousand Oaks
91362
California
UNITED STATES