Product Wiki · Recalls · Health Canada — Medical Devices

Inserter for Titanium Elastic Nails (2015-02-25) — recall 53340

Health Canada — Medical Devices · Canada · 2015-03-27 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
53340
Date of alert
2015-03-27
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: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/inserter-titanium-elastic-nail

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