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Porte-implant Synfix-LR (2013-11-06)
- Starting date:
- November 6, 2013
- Posting date:
- December 4, 2013
- 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-36989
Recalled products
A. Synfix-LR Implant Holder
Reason
Complaints have been received which describe the Synfix LR Implant Holder breaking at the interface between the implant and holder. If an unretrieved device fragment remains threaded into the plate, it will not be possible to properly attach the Synfix aiming device to the implant (Plate). Proper attachment of the aiming device to the plate is required for accurate insertion of the four Synfix screws into the Synfix implant (Plate) and verebral bodies. If the tip holder should break, the potential exists for an untretrieved device fragment to be left in the Synfix-LR implant.
Affected products
A. Synfix-LR Implant Holder
Lot or serial number
All lots
Model or catalog number
- 03.802.039
Companies
- Manufacturer
-
Synthes (Canada) Ltd.
2566 Meadowpine Blvd.
Mississauga
L5N 6P9
Ontario
CANADA