—#100416

Product

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.

FDA product code: FTL — Mesh, Surgical, Polymeric
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K071957
Affected lot / code info: Catalog/UPC: M0068317100, Lot: 1ML0072001. Catalog/UPC M0068317050, Lot: 1ML0070801.

Why it was recalled

The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Worldwide Distribution; (USA) Nationwide distribution, and the countries of Puerto Rico, France, Great Britain, Ireland, Italy, Spain, Sweden, Canada, and Australia.

Timeline

Recall initiated: 2011-05-10
Posted by FDA: 2011-08-03
Terminated: 2011-11-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100416. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.