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Weck EFX Endo Facial Closure System
- Starting date:
- November 16, 2016
- Posting date:
- December 5, 2016
- 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-61296
Reason
The device's wings may partially detach from the EFx shield during use. The wings are secured to the device at two points, therefore they are not completely detaching from the device. The partial detachment makes removal of the device from the patient more difficult and there is potential the incision site may need to be enlarged in order to remove the device.
Affected products
Recalls and Safety Alerts - Management System
Weck EFX Endo Facial Closure System
Lot or serial number
3264480000
3269990000
3270100000
Model or catalog number
EFX002
Companies
- Manufacturer
-
Teleflex Medical
2917 Weck Drive
Research Triangle Park
27709
North Carolina
UNITED STATES