Recall Z-1539-2012 ยท GWG Endoscope, Neurological
Mitaka USA, Inc.
Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures.
| Date | May 11, 2012 (initiated Feb 27, 2009) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984355 | POINT SETTER Mitaka USA, Inc., Apr 1, 1999 |