Health product recall

Parietex Composite Parastomal Mesh (2018-10-08)

Starting date:
October 8, 2018
Posting date:
October 19, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-68050

Affected products

Parietex Composite Parastomal Mesh

Reason

Medtronic is issuing a voluntary recall for two item codes of its covidien parietex composite parastomal mesh following receipt of reports of Parietex Composite Parastomal Mesh failure identified several years following parastomal hernia repair using the modified sugarbaker repair technique. In these reports, Parietex Composite Parastomal Mesh failure led to hernia recurrence requiring additional surgical treatment. Symptoms of hernia recurrence may include discomfort, localized pain-free or painful bulging, and possible changes in the overlying skin

Affected products

Parietex Composite Parastomal Mesh

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

PCOPM15
PCOPM20

Companies
Manufacturer

Sofradim Production

116 Avenue du Formans

Trévoux

01600

FRANCE