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Aequalis - Humeral Implant Broach (2014-12-08)
- Starting date:
- December 8, 2014
- Posting date:
- December 23, 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-42983
Recalled Products
Aequalis - Humeral Implant Broach
Reason
The recall has been initiated as a preventive action, following the identification of a risk of fragility of some parts over time resulting in breakage of the humeral broaches during surgery. Several incidents have been registered describing breakage of some humeral broaches. Following these complaints, Tornier determined that new broaches will replace the old ones.
Affected products
Aequalis - Humeral Implant Broach
Lot or serial number
Not applicable
Model or catalog number
- MWA025
- MWA026
- MWA027
Companies
- Manufacturer
-
TORNIER SAS
161 Lavoisier Street
Montbonnot Cedex, Saint Martin
38330
FRANCE