Recall Z-0419-2011 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew FAST FIX 360, STRAIGHT NEEDLE Catalog Number; 72202467. Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair, and gastrostomy.
| Date | Nov 18, 2010 (initiated Oct 14, 2010) |
| Status | Terminated |
| Reason | FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 53 units |
| Distribution | Worldwide Distribution - USA, Dubai, and Great Britain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092508 | FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT, Smith & Nephew, Inc., Jan 28, 2010 |