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.
FDA Recall Z-0324-2016 · Posted 2015-11-20
Recalling FirmPega Medical Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2015-10-20
Date Terminated2016-08-16
Product Quantity4 units distributed in the US
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.
Firm Action
The firm sent the Urgent Field Safety Notice-Recalls to US consignees via email. Consignees are advised to return affected devices back to the firm.
Customer with questions can contact Enrique Garcia at 450-688-5144 ext. 242 or send email to [email protected]
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
Distributed in the states of FL and TN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.