Recall Z-2931-2011 ยท FTL Mesh, Surgical, Polymeric
Boston Scientific Corporation
Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repair Kit--Posterior STERILE. Boston Scientific, Corp. Indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
| Date | Aug 3, 2011 (initiated May 10, 2011) |
| Status | Terminated |
| Reason | The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement. |
| Root cause | Device Design |
| Action | Boston Scientific Corporation sent on May 10, 2011 an "URGENT MEDICAL DEVICE RECALL-IMMEDIATE ACTION REQUIRED" letter to all affected customers. The letter included; reason for recall, instructions for the quarantine, discontinued use, and return of the devices, and information for Medwatch reporting. The letter also includes a form that is to be faxed to the firm. For information call (508) 683-4678. |
| Quantity | 540 |
| Distribution | Worldwide Distribution; (USA) Nationwide distribution, and the countries of Puerto Rico, France, Great Britain, Ireland, Italy, Spain, Sweden, Canada, and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071957 | PINNACLE PELVIC FLOOR REPAIR KITS Boston Scientific Corp, Nov 8, 2007 |