FDA Medical Device Recalls (openFDA)
Mitaka USA, Inc.: Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures.
- Recall number
- Z-1539-2012
- Recalling firm
- Mitaka USA, Inc.
- Product
- Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures.
- Status
- Terminated
- Initiated
- 2009-02-27
- Posted
- 2012-05-11
- Terminated
- 2012-05-22
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Inddivdual Serial Numbers - 18 total: 70952; 70972; 71002; 71012; 71022; 71032; 71042; 71052; 71062; 71082; 71102; 71112; 71122; 71142; 81162; 81172; 81182; 81192.
- 510(k) numbers
- ["K984355"]
- PMA numbers
- not on file
- Product code
- GWG
- Firm FEI
- 3002996788
- Firm city
- Park City
- Firm state
- UT
- 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