Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures.
FDA device recall Z-1539-2012 · posted 2012-05-11 · Terminated
Recall details
- Recalling firm
- Mitaka USA, Inc.
- 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.
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- GWG
- Quantity affected
- 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.
- Date initiated
- 2009-02-27
- Date posted
- 2012-05-11
- Date terminated
- 2012-05-22
- Location
- Park City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POINT SETTER (K984355) | Mitaka USA, Inc. | 1999-04-01 |