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Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
- Starting date:
- November 4, 2016
- Posting date:
- December 13, 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-61392
Reason
When the torque defining screw is tightened to the torque required to disengage the screw head, the screw head will disengage as expected, but it may not be retained in the torque defining screwdriver.
This may cause a delay in surgery of less than 1 minute due to the need to pick up the screw head that was not retained by the driver. Surgeons should also be advised that there is a potential for the screw head to fall into the wound site.
Affected products
Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
320-20-00
Companies
- Manufacturer
-
EXACTECH INC.
2320 NW 66TH COURT
GAINESVILLE
32653
Florida
UNITED STATES