Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repair Kit--Posterior STERILE. Bost
FDA device recall Z-2931-2011 · posted 2011-08-03 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.
- Action taken
- 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
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 540
- Distribution
- Worldwide Distribution; (USA) Nationwide distribution, and the countries of Puerto Rico, France, Great Britain, Ireland, Italy, Spain, Sweden, Canada, and Australia.
- Date initiated
- 2011-05-10
- Date posted
- 2011-08-03
- Date terminated
- 2011-11-15
- Location
- Marlborough, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PINNACLE PELVIC FLOOR REPAIR KITS (K071957) | Boston Scientific Corp | 2007-11-08 |