Device product
Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
Z-1848-2015
Product summary
- Event
- Event 71560
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1848-2015
Official wording
Reason: SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation.
Code information: Part Number: SCF-MLD265, LOT#: 130703-01. Part Number: SCF-MLD273, LOT#: 130703-02.
Distribution pattern: US Distribution to the states of : FL and TN.
Derived failure modes
-
Unknown
SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation.