Arthrex Angel BMC Kit & cPRP Processing Set (2021-04-01)

Starting date:

April 1, 2021

Posting date:

April 20, 2021

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-75421

Last updated:
2021-07-06

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  Reason
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  Affected products

Affected Products 

1. Arthrex Angel BMC Kit
2. Angel cPRP Processing Set

Reason

Arthrex recently became aware that ABS-10063 and ABS-10064 devices may not have been sterilized appropriately by a 3rd party organization and therefore is unable to guarantee the sterility of these devices and is removing the devices from the market. All associated kits listed above utilize either ABS-10063 or ABS-10064 and are also affected. Arthrex has not identified any reports of adverse events or serious patient harm to date that could be associated to this field safety corrective action.

Affected products