FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc. Endoscopy Division: FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number: 7209399
- Recall number
- Z-0798-06
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Product
- FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number: 7209399
- Status
- Terminated
- Initiated
- 2006-03-24
- Posted
- 2006-04-26
- Terminated
- 2007-12-12
- Reason
- The implant consists of a T1 and T2 anchor which are joined together by a suture. The T2 portion of the implant may not advance into the deployment position preventing deployment of the T2 anchor.
- Root cause
- Other
- Action
- Smith & Nephew notified accounts by letter dated 3/24/06 issued by Federal Express. Users are requested to return product.
- Quantity
- 1800 units
- Distribution
- Nationwide Foreign: Austria, Germany, France, Italy, Australia
- Lot, serial or model codes
- Lot Numbers: 50141993, 50145519, 50146091,50146096, 50146362, 50148283, 50146365, 50153066, 50150381
- 510(k) numbers
- ["K020480"]
- PMA numbers
- not on file
- Product code
- KGS
- 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