SmartStitch Suturing Device - PerfectPasser Connector (2019-02-21)
- Starting date:
- February 21, 2019
- Posting date:
- March 8, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-69242
Affected Products
SmartStitch Suturing Device - PerfectPasser Connector
Reason
The devices are recalled due a manufacturing error resulting in incorrect upper jaw dimensions. Confirmed complaints indicated that the upper jaw could potentially disengage or detach during use.
Affected products
SmartStitch Suturing Device - PerfectPasser Connector
Lot or serial number
More than 10 numbers. Contact manufacturer.
Model or catalog number
OM-8010
Companies
- Manufacturer
-
Arthrocare Corporation,
7000 W. William Cannon Drive,
Austin
78735
Texas
UNITED STATES