Health product recall

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

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

A. Arthrex Angel BMC Kit

Lot or serial number

lot # 0141103940

Model or catalog number

ABS-10062

Companies
Manufacturer

Arthrex Inc.

1370 Creekside Boulevard

Naples

34108-1945

Florida

UNITED STATES

B. Angel cPRP Processing Set

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

ABS-10063

Companies
Manufacturer

Arthrex Inc.

1370 Creekside Boulevard

Naples

34108-1945

Florida

UNITED STATES