FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc. Endoscopy Division: 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.
- Recall number
- Z-0421-2011
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- 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.
- Status
- Terminated
- Initiated
- 2010-10-14
- Posted
- 2010-11-18
- Terminated
- 2012-05-09
- 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
- 130 units
- Distribution
- Worldwide Distribution - USA, Dubai, and Great Britain.
- Lot, serial or model codes
- Lot Numbers: 50327272, 50327427, 50327430, and 50328898.
- 510(k) numbers
- ["K092508"]
- PMA numbers
- not on file
- Product code
- GAT
- Firm FEI
- 3003604053
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28