TIO2MESH

Description of Event or Problem

BIOCER B)(4) HAS BEEN INFORMED BY (B)(4), DIVISION MEDICAL DEVICES, (B)(4) ON A POTENTIAL COMPLICATION USING TIO2MESH SURGICAL MESH IMPLANTS. IN A FEW EXCEPTIONAL CASES AND ONLY UNDER CERTAIN CONDITIONS IT CAN HAPPEN THAT AFTER AN INCISION PARALLEL TO THE BLUE ORIENTATION STRIPES A SO-CALLED LADDER IS FORMED AND A PROPAGATION OF THE TEAR WITHOUT ANY FORCE EFFECT WILL RESULT. THE PROBLEM IS NOTED PRIOR USE OF THE DEVICE. TO PREVENT THIS EVENTUALITY IN FUTURE, BIOCER EXTENDS THE INSTRUCTIONS FOR USE OF TIO2MESH WITH A WARING: INCISIONS AND CAVITIES PARALLEL TO THE BLUE ORIENTATION STRIPES SHOULD GENERALLY BE AVOIDED. FOR INDICATIONS IN WHICH AN INCISION IS REQUIRED SPECIALLY MANUFACTURED MESH IMPLANTS ARE PROVIDED BY THE MANUFACTURER. BIOCER HAS ALREADY RECEIVED THE NCAR FROM (B)(4). CONSIDERS THIS CORRECTIVE ACTION TO BE SUFFICIENT FOR RISK REDUCTION. THE PRODUCT TIO2MESH IS NOT YET DISTRIBUTED IN THE USA.