Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 Mm, 83 Mm Long

Recall Summary A shoulder implant called the Comprehensive Shoulder System Mini Humeral Stem (Porous Plasma, 15 mm, 83 mm long) is being recalled in Canada because of an increased risk of adverse events. This implant was distributed across Canada. The recall is classified as Class I, meaning there is a serious potential health risk associated with the product.

Product
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 Mm, 83 Mm Long
Reason
Increased risk or new adverse events
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2022-01-17
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/cf057e6f-ce51-4324-ab86-b9676788fbd9