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Vectra System Titanium (Ti) Plate Four Level (2014-09-05)
- Starting date:
- September 5, 2014
- Posting date:
- September 16, 2014
- 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-41353
Recalled products
- Vectra System - Titanium (Ti) Plate Four Level
Reason
The Elgiloy Clips are potentially missing from the Ti Vectra plate resulting in the inability to lock the screw onto the plates. The affected device may be missing all eight (8) clips from the screw holes. Vectra plating systems include several options that have integral Elgiloy clips. The purpose of the clips is twofold: to hold the drill guide in place during the site preparation and to lock the screws into the implant to assist with stability and help prevent screw back-out.
Affected products
A. Vectra System - Titanium (Ti) Plate Four Level
Lot or serial number
- 8143905
Model or catalog number
- 04.613.364
Companies
- Manufacturer
-
Synthes (Canada) Ltd.
2566 Meadowpine Blvd.
Mississauga
L5N 6P9
Ontario
CANADA