Health product recall

Acumed Cortical Screws (2018-06-07)

Starting date:
June 7, 2018
Posting date:
July 5, 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-67172

Affected products

Acumed Cortical Screws

Reason

It has come to Acumed's attention that there has been a commingling of two batches of 3.5mm Cortical Screws (10.0mm and 12.0mm). As a result, there is a possibility of mislabeling which could result in implantation difficulty or user annoyance if the screw lengths are not verified before use.

Affected products

Acumed Cortical Screws

Lot or serial number

420857

Model or catalog number

CO-3100-S

CO-3120-S

Companies
Manufacturer

Acumed LLC

Corenelius Pass Road NW

Hillsboro

97124

Oregon

UNITED STATES