Events

Recall of Device Recall SCFE Drivers of the FreeGliding SCFE Screw System

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
    71560
  • Event Risk Class
    Class 2
  • Event Number
    Z-1848-2015
  • Event Initiated Date
    2015-06-15
  • Event Date Posted
    2015-06-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138189
  • 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 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.
  • Action
    Pega Medical sent an Urgent Field Safety-Recall letter via email on June 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advise on action to be taken by the customer: ¿ Identify the device with the same catalogue number and lot number ¿ Return the device to Pega Medical Inc. to the address shown below using the FedEx account. For further questions please call the firm at 450-688-5144 x. 242.

Device

Device Recall SCFE Drivers of the FreeGliding SCFE Screw System
  • 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
    US Distribution to the states of : FL and TN.
  • Product Description
    Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
  • 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