Z-2931-2011

Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repair Kit--Posterior...

Name: Z-2931-2011 Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repair Kit--Posterior...
Creator: Boston Scientific Corporation
Published: 2011-05-10
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2011-05-10 / Terminated / root cause: design

FDA source

Boston Scientific Corporation began a recall of Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repair Kit--Posterior STERILE. Boston Scientific, Corp. Indicated for... on 2011-05-10. The reason FDA records is "The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2931-2011
Status: Terminated
Initiated: 2011-05-10
Posted: 2011-08-03
Terminated: 2011-11-15
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.
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.
Root cause tag: design
FDA 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 in commerce: 540
Distribution: Worldwide Distribution; (USA) Nationwide distribution, and the countries of Puerto Rico, France, Great Britain, Ireland, Italy, Spain, Sweden, Canada, and Australia.
Product codes and lots: Catalog/UPC: M0068317100, Lot: 1ML0072001. Catalog/UPC M0068317050, Lot: 1ML0070801.

Product code FTL

K071957Class IIIPinnacle Pelvic Floor Repair KitsBoston Scientific Corp / cleared 2007-11-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)