PHYSIOMESH FLEXIBLE COMPOSITE MESH (2016-05-25)
- Starting date:
- May 25, 2016
- Posting date:
- June 13, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-58846
Affected products
A. PHYSIOMESH FLEXIBLE COMPOSITE MESH
Reason
Ethicon is recalling the product following an analysis of unpublished data from two large independent hernia registries. Recurrence / reoperation rates (respectively) after Laparoscopic Ventral Hernia Repair using ETHICON PHYSIOMESH Flexible Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries. Ethicon is unable at this time to characterize all factors contributing to higher rates and is therefore removing the product from the global market.
Affected products
A. PHYSIOMESH FLEXIBLE COMPOSITE MESH
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- PHY0715R
- PHY1015V
- PHY1515Q
- PHY1520R
- PHY1520V
- PHY2025V
- PHY2030R
- PHY2535V
- PHY3035R
- PHY3050R
Companies
- Manufacturer
-
JOHNSON & JOHNSON INTERNATIONAL, C/O EUROPEAN LOGISTICS CENTRE
LEONARDO DA VINCILAAN, 15, DIEGEM
BELGIUM