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Health product recall

Inserter for Titanium Elastic Nails (2015-02-25)

Starting date:
February 25, 2015
Posting date:
March 27, 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-52697

Recalled Products

A. Inserter for Titanium Elastic Nails

Reason

Synthes (Canada), Ltd. received notification from its supplier, Synthes (USA), that a determination had been made that a voluntary recall would be performed. It was reported the inserter for Titanium Elastic Nails (TEN) has the potential for mechanical failures such as breakage of the main shaft of the inserter for the ten, malfunction of the chuck of the inserter for the TEN in the form of the chuck getting stuck/jammed, breakage of the cross bar of the inserter for the TEN as a result of hammering, and failure of the back end of the inserter by loosening and falling off.

Affected products

A. Inserter for Titanium Elastic Nails

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

359.219

Companies
Manufacturer
Synthes (Canada) Ltd.
2566 Meadowpine Blvd.
Mississauga
Ontario
CANADA