Product Wiki · Recalls · Health Canada — Medical Devices

Standard Offset Cup Impactors (2014-03-28) — recall 52408

Health Canada — Medical Devices · Canada · 2014-09-09 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
52408
Date of alert
2014-09-09
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Greatbatch has determined that when a Standard Offset Cup Impactors is sterilized per the current instructions for use (IFU), the device may not be sterile. Similarly, if the device is removed from the sterilizer after being sent through steam sterilization per the IFU provided, it might not remain sterile because it is not completely dry.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/standard-offset-cup-impactors-

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