Product Wiki · Recalls · Health Canada — Medical Devices

DGDE- DIRECTGUIDE DRILL EXTENDER (2015-10-23) — recall 54129

Health Canada — Medical Devices · Canada · 2015-10-23 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54129
Date of alert
2015-10-23
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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%).
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/dgde-directguide-drill-extende

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