Pega Medical Inc.: Medical Device Recall in 2015 - (Recall #: Z-0324-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 20, 2015

Date Posted: December 2, 2015

Recall Number: Z-0324-2016

Event ID: 72529

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.

Status: Terminated

Product Quantity: 4 units distributed in the US

Code Information:

Part Number: SCF-MLD265; LOT#: 130703-01 Part Number: SCF-MLD273; LOT#: 130703-02

Distribution Pattern:

Distributed in the states of FL and TN.

Voluntary or Mandated:

Voluntary: Firm initiated