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Guided Handle Kit (2017-11-01)
- Starting date:
- November 1, 2017
- Posting date:
- November 22, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-65204
Affected products
Guided Handle Kit
Reason
The 3.4 mm guide insert will not allow the 3.4 drill to pass through, since the diameter is too small. Also, the 2.3 mm guide was too large.
Affected products
Guided Handle Kit
Lot or serial number
38665
42562
45014
52987
64245
Model or catalog number
G-HK
Companies
- Manufacturer
-
Implant Direct Sybron Manufacturing LLC
3050 East Hillcrest Drive
Thousand Oaks
91362
California
UNITED STATES