Recall Z-1539-2012
Mitaka USA, Inc. · initiated February 27, 2009
Product
Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures.
Codes / lots: Inddivdual Serial Numbers - 18 total: 70952; 70972; 71002; 71012; 71022; 71032; 71042; 71052; 71062; 71082; 71102; 71112; 71122; 71142; 81162; 81172; 81182; 81192.
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.
FDA-determined cause: Component design/selection
Action taken
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.
Details
- Recall number
- Z-1539-2012
- Initiated
- February 27, 2009
- Posted by FDA
- May 11, 2012
- Terminated
- May 22, 2012
- Product code
- GWG – Endoscope, Neurological
- 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.
- Recalling firm
- Mitaka USA, Inc., Park City, UT