Health product recall

SCFE Knobs part of the Free-Gliding SCFE Screw System (2019-10-02)

Starting date:
October 2, 2019
Posting date:
October 11, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-71267

Last updated: 2019-10-11

Affected Products

SCFE Knobs part of the Free-Gliding SCFE Screw System

Reason

The SCFE knobs found in the free gliding SCFE screw system are a sub-assembly used to hold the internally threaded shaft into de SCFE driver handle.

These sub-assemblies are fastened with two screws. It has been observed that the vibration produced during the ultrasonic cleaning may cause the loosening of the screws of the driver's knob. This situation leads to the loosening of the knob assemblies becoming dysfunctional.

Affected products

SCFE Knobs part of the Free-Gliding SCFE Screw System

Lot or serial number
  • 160428-03
  • 160428-04
  • 160603-05
  • 160603-06
  • A182-05
  • A182-15
  • A183-02
    Model or catalog number
    • SCF-KNB265
    • SCF-KNB273
    • SCF-KNB365
    • SCF-KNB373
    Companies
    Manufacturer
    Pega Medical Inc.
    111 autoroute Chomedey
    Laval
    H7W 5J8
    Quebec
    CANADA