Z-1972-2010

Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting and coagulation...

Name: Z-1972-2010 Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting and coagulation...
Creator: Starion Instruments
Published: 2008-06-26
License: https://open.fda.gov/license/

Microline Surgical, Inc / initiated 2008-06-26 / Terminated / root cause: manufacturing process

FDA source

Starion Instruments began a recall of Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting and coagulation device and accessories, manufactured by Starion... on 2008-06-26. The reason FDA records is "Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1972-2010
Status: Terminated
Initiated: 2008-06-26
Posted: 2010-07-09
Terminated: 2010-10-27
Recalling firm: Microline Surgical, Inc
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 217 units
Distribution: Worldwide distribution.
Product codes and lots: Model Number N-10700, lot numbers 80419, 806009, 804037, 804035, 804036, 804019A.

Product code GEI

K062257Class IIStarion Instruments Thermal Litigating ShearsStarion Instruments / cleared 2006-10-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)