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