FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2931-2011
- Recalling firm
- Boston Scientific Corporation
- 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.
- Status
- Terminated
- Initiated
- 2011-05-10
- Posted
- 2011-08-03
- Terminated
- 2011-11-15
- 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.
- Lot, serial or model codes
- Catalog/UPC: M0068317100, Lot: 1ML0072001. Catalog/UPC M0068317050, Lot: 1ML0070801.
- 510(k) numbers
- ["K071957"]
- PMA numbers
- not on file
- Product code
- FTL
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28