Health product recall

Mitek Screw and Washer Depth Gauge (2018-08-30)

Starting date:
August 30, 2018
Posting date:
September 17, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67768

Affected products

Mitek Screw and Washer Depth Gauge

Reason

DePuy Mitek has received reports of the Mitek Screw and washer depth gauge measuring incorrectly. An investigation determined the depth gauge has an offset in the design that result in a reading approximately 3.2mm shorter than the actual length of the bone hole. This field safety notice is for the removal of all lots.

Affected products

Mitek Screw and Washer Depth Gauge

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

219024

Companies
Manufacturer

Depuy Mitek

325 Paramount Drive

Raynham

02767

Massachusetts

UNITED STATES