Z-1539-2012

Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating...

Name: Z-1539-2012 Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating...
Creator: Mitaka USA, Inc.
Published: 2009-02-27
License: https://open.fda.gov/license/

Mitaka USA, Inc. / initiated 2009-02-27 / Terminated / root cause: design

FDA source

Mitaka USA, Inc. began a recall of Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures on 2009-02-27. The reason FDA records is "Use of a potentially weaker spring in the device than required to meet specifications to hold the Point Setter ARM in place during surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1539-2012
Status: Terminated
Initiated: 2009-02-27
Posted: 2012-05-11
Terminated: 2012-05-22
Recalling firm: Mitaka USA, Inc.
Product: Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures.
Product code: GWG Endoscope, Neurological
Reason for recall: Use of a potentially weaker spring in the device than required to meet specifications to hold the Point Setter ARM in place during surgery.
Root cause tag: design
FDA root cause: Component design/selection
Action: Mitaka USA sent a letter dated to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter included instructions for returning the product. Contact the Customer Support Department at 800-421-0837, ext. 7577 for questions regarding this notice.
Quantity in commerce: 18 units (3 internationally and 15 within the U.S.)
Distribution: Worldwide Distribution-USA (nationwide) including the states of AZ, FL, CA, SC, OH, WA, TX, VA, MI, MO, GA, and NC and the country of Canada.
Product codes and lots: Inddivdual Serial Numbers - 18 total: 70952; 70972; 71002; 71012; 71022; 71032; 71042; 71052; 71062; 71082; 71102; 71112; 71122; 71142; 81162; 81172; 81182; 81192.

Product code GWG

K984355Class IIPoint SetterMitaka USA, Inc. / cleared 1999-04-01

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)