Health product recall

Graphic Cases for 6.5 mm and 7.3 mm Cannulated Screw Sets (2018-03-06)

Starting date:
March 6, 2018
Posting date:
March 23, 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-66272

Affected products

Graphic Cases for 6.5 mm and 7.3 mm Cannulated Screw Sets

Reason

DePuy Synthes is conducting a lot-specific recall of the graphic cases for 6.5mm and 7.3mm cannulated screw sets because they contain screw gauges that incorrectly measure screws 5.41mm shorter than the actual overall screw length. Thus, when using the measuring gauge, the surgeon would potentially be inserting a screw which is 5.41mm shorter than intended.

Affected products

Graphic Cases for 6.5 mm and 7.3 mm Cannulated Screw Sets

Lot or serial number

FL00860
H340372

Model or catalog number

690.375-US
690.379-US
690.380-US

Companies
Manufacturer
Synthes USA LLC
1101 SYNTHES AVENUE
Monument
80132
Colorado
UNITED STATES