Smith & Nephew FAST FIX 360, REVERSE CURVED NEEDLE Catalog Number; 72202469. Intended for use as a suture retention devi
FDA device recall Z-0421-2011 · posted 2010-11-18 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Reason for recall
- FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation.
- Action taken
- Smith & Nephew notified customers by an Urgent - Product Recall 1st Notification - Urgent letter sent via Federal Express October 14, 2010. The letter identified the affected product and explained the problem. The letter asked customers to call for a Return Authorization (RA) Number. Customers are to complete the form and return of the affected product along with a copy of the letter to the address provided being sure to reference the RA number. Questions were to be directed to Cindy Burns at 508-261-3655. Consignees out side the US were notified by e-mail.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GAT
- Quantity affected
- 130 units
- Distribution
- Worldwide Distribution - USA, Dubai, and Great Britain.
- Date initiated
- 2010-10-14
- Date posted
- 2010-11-18
- Date terminated
- 2012-05-09
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT, (K092508) | Smith & Nephew, Inc. | 2010-01-28 |