FDA Medical Device Recalls (openFDA)
Rita Medical Systems, Inc.: Talon Straight, 25 cm--Electrosurgical Device--RITA * Medical Systems, Inc. * StarBurst Talon * * REF: 700-102846 * 4 cm Diameter * 25 cm Length * Sterile/R * Catalog # 700-102846-RITA * Manufactured by: Rita Medical Systems, Inc., One Horizon Way, Manchester, Georgia 31816, USA
- Recall number
- Z-0887-06
- Recalling firm
- Rita Medical Systems, Inc.
- Product
- Talon Straight, 25 cm--Electrosurgical Device--RITA * Medical Systems, Inc. * StarBurst Talon * * REF: 700-102846 * 4 cm Diameter * 25 cm Length * Sterile/R * Catalog # 700-102846-RITA * Manufactured by: Rita Medical Systems, Inc., One Horizon Way, Manchester, Georgia 31816, USA
- Status
- Terminated
- Initiated
- 2006-05-02
- Posted
- 2006-05-31
- Terminated
- 2008-02-05
- Reason
- Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker.
- Root cause
- Other
- Action
- Consignees were first notified by telephone on 05/02/2006. A follow up letter was sent on 05/03/2006. The European Medical Device Agency, the Italian Competent Authority and British Standards Institution were notified by email on 05/03/2006.
- Quantity
- 21 units
- Distribution
- AL, AR, FL, LA, MA, NJ, NY, PA, TN, TX, UT and Italy
- Lot, serial or model codes
- Catalog number: 700-102846 , Lot number 25969
- 510(k) numbers
- ["K010060"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3017892510
- Firm city
- Manchester
- Firm state
- GA
- 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