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
- Arthrex Angel BMC Kit
- 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