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