Recall Z-0421-2011
Smith & Nephew, Inc. Endoscopy Division · initiated October 14, 2010
Product
Smith & Nephew FAST FIX 360, REVERSE CURVED NEEDLE Catalog Number; 72202469. 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.
Codes / lots: Lot Numbers: 50327272, 50327427, 50327430, and 50328898.
Reason for recall
FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-0421-2011
- Initiated
- October 14, 2010
- Posted by FDA
- November 18, 2010
- Terminated
- May 9, 2012
- Product code
- GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
- Quantity
- 130 units
- Distribution
- Worldwide Distribution - USA, Dubai, and Great Britain.
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division, Andover, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0419-2011 | Smith & Nephew FAST FIX 360, STRAIGHT NEEDLE Catalog Number; 72202467. Intended for use…FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation. | 10/14/2010Terminated |
| Z-0420-2011 | Smith & Nephew FAST FIX 360, CURVED NEEDLE Catalog Number; 72202468. Intended for use as…FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation. | 10/14/2010Terminated |