CanadaIntramedullary Bone Saw Blade Assembly units sold under Biomet Orthopedics, Ata Biomet Sports Medicine, Ata Biomet Biologics and Ata Biomet Trauma with lot/serial numbers 67818764 (catalogue 475630), 67818770 (catalogue 475635) and 67818791 (catalogue 475620) are affected. They were recalled because the tip protector was placed on the blunt end instead of the saw blade, leaving the blade exposed and potentially damaging the sterile barrier pouch, which could lead to loss of sterility. Contact the manufacturer for additional information.
What's being recalled
Companies: Biomet Orthopedics, Ata Biomet Sports Medicine, Ata Biomet Biologics, Ata Biomet Trauma, 56 East Bell Drive, Warsaw, Indiana, United States, 46581.
How to identify it
Affected products: Intramedullary Bone Saw Blade Assembly; Lot or serial number: 67818764; Model or catalogue number: 475630
Affected products: Intramedullary Bone Saw Blade Assembly; Lot or serial number: 67818770; Model or catalogue number: 475635
Affected products: Intramedullary Bone Saw Blade Assembly; Lot or serial number: 67818791; Model or catalogue number: 475620
The hazard
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Sawblade Assembly due to potential sterile barrier packaging damaged caused by the exposed saw blade. It was identified internally that the tip protector was incorrectly placed on the blunt end of the device instead of the sawblade, leaving the saw blade exposed. The exposed saw blade has potential to damage the sterile barrier pouch, which has potential to result in loss of sterility. There have been zero complaints received.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)