Events

Recall of SCFE Driver

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pega Medical Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72529
  • Event Risk Class
    Class 2
  • Event Number
    Z-0324-2016
  • Event Initiated Date
    2015-10-20
  • Event Date Posted
    2015-11-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141449
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Screw, fixation, bone - Product Code HWC
  • Reason
    Scfe driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
  • 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 egarcia@pegamedical.com

Device

SCFE Driver
  • Model / Serial
    Part Number: SCF-MLD265; LOT#: 130703-01 Part Number: SCF-MLD273; LOT#: 130703-02
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of FL and TN.
  • 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.
  • Manufacturer
    Pega Medical Inc.

Manufacturer

Pega Medical Inc.
  • Manufacturer Address
    Pega Medical Inc., 1111 Autoroute Chomedy, Laval Canada
  • Manufacturer Parent Company (2017)
    Pega Medical Inc.
  • Source
    USFDA