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 Recall Z-2931-2011 · Posted 2011-08-03
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFTL
Date Initiated2011-05-10
Date Terminated2011-11-15
Product Quantity540
Reason for Recall
The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution; (USA) Nationwide distribution, and the countries of Puerto Rico, France, Great Britain, Ireland, Italy, Spain, Sweden, Canada, and Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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