Z-0324-2016 Class II Terminated
FDA device recall Z-0324-2016 was initiated by Pega Medical Inc. on October 20, 2015 and is designated Class II. Reason for recall: SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw. The recall status is terminated (terminated August 16, 2016). Affected quantity: 4 units distributed in the US.
Recall Details
- Product Type
- Devices
- Report Date
- December 2, 2015
- Initiation Date
- October 20, 2015
- Termination Date
- August 16, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units distributed in the US
Product Description
SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic.
Reason for Recall
SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
Distribution Pattern
Distributed in the states of FL and TN.
Code Information
Part Number: SCF-MLD265; LOT#: 130703-01 Part Number: SCF-MLD273; LOT#: 130703-02