Health product recall

BioComposite SwiveLock (2021-06-08)

Starting date:
June 8, 2021
Posting date:
June 30, 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-75929

Last updated:
2021-06-30

Affected Products

BioComposite SwiveLock

Reason

All devices in scope were potentially not sealed properly while undergoing the Tyvek header sealing process. As a result, there is a potential that the products in scope were not properly sterilized and presents a risk to health.

Affected products

BioComposite SwiveLock

Lot or serial number

12758314
13022357

Model or catalog number

AR-2323BCC

Companies
Manufacturer

Arthrex Inc.

1370 Creekside Boulevard

Naples

34108-1945

Florida

UNITED STATES