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DGDE- DIRECTGUIDE DRILL EXTENDER (2015-10-23)
- Starting date:
- October 23, 2015
- 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-56292
Affected Products
DGDE- DIRECTGUIDE DRILL EXTENDER
Reason
Implant Direct Sybron Manufacturing LLC is recalling 3 lots of the DGDE Direct Guide Drill Extender (DGDE) and 22 lots of associated products that contain DGDE as an accessory. Through internal Regulatory Affairs evaluation (HHE) process, the company found a possible safety issue with the retention of the drill when the DGDE is in use. This discrepancy may lead to the possibility of the DGDE dropping the drill. The company's current data indicates the possibility of this occurring is unlikely (0.69%).
Affected products
DGDE- DIRECTGUIDE DRILL EXTENDER (2015-10-23)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- BST
- CST
- DGDE
- IBST
- ICST
- RBST
- RCST
- SPCST
Companies
- Manufacturer
-
Implant Direct Sybron Manufacturing LLC
3050 East Hillcrest Drive
Thousand Oaks
91362
California
UNITED STATES