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.
This recall has been terminated (originally issued November 18, 2010).
- Recall Initiated
- October 14, 2010
- Posted
- November 18, 2010
- Terminated
- May 9, 2012
- Recall Number
- Z-0421-2011
- Quantity
- 130 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation.
Distribution
Worldwide Distribution - USA, Dubai, and Great Britain.
Lot / Code Info
Lot Numbers: 50327272, 50327427, 50327430, and 50328898.
Root 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.