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

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  Reason
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  Affected products

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