FDA Medical Device Recalls (openFDA)
Starion Instruments: Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments, Sunnyvale, CA Intended use: Medical Device used for cutting and cauterization of soft tissue during surgery, and of natural or synthetic, non-metallic sutures during surgery.
- Recall number
- Z-1972-2010
- Recalling firm
- Starion Instruments
- Product
- Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments, Sunnyvale, CA Intended use: Medical Device used for cutting and cauterization of soft tissue during surgery, and of natural or synthetic, non-metallic sutures during surgery.
- Status
- Terminated
- Initiated
- 2008-06-26
- Posted
- 2010-07-09
- Terminated
- 2010-10-27
- Reason
- Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use.
- Root cause
- Process control
- Action
- The firm submitted an MDR but determined that there was no risk to health. E-mails were sent on June 26, 2008, to consignees, describing the product, the problem, and action to be taken by consignees. The consignees were ask to provide a list of all unused ThermaSeal devices and their locations, to return the products to Starion from the lots noted and to provide a copy of the attached letter to their sales force and customers if they choose. If you have any questions, please call (408) 522-5200 ext. 326 or (408) 350-9934.
- Quantity
- 217 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- Model Number N-10700, lot numbers 80419, 806009, 804037, 804035, 804036, 804019A.
- 510(k) numbers
- ["K062257"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1000137656
- Firm city
- Sunnyvale
- Firm state
- CA
- 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