Mitaka USA, Inc. Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures.
Brand
Mitaka USA, Inc.
Lot Codes / Batch Numbers
Inddivdual Serial Numbers - 18 total: 70952, 70972, 71002, 71012, 71022, 71032, 71042, 71052, 71062, 71082, 71102, 71112, 71122, 71142, 81162, 81172, 81182, 81192.
Products Sold
Inddivdual Serial Numbers - 18 total: 70952; 70972; 71002; 71012; 71022; 71032; 71042; 71052; 71062; 71082; 71102; 71112; 71122; 71142; 81162; 81172; 81182; 81192.
Mitaka USA, Inc. is recalling Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during o due to Use of a potentially weaker spring in the device than required to meet specifications to hold the Point Setter ARM in place during surgery.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Use of a potentially weaker spring in the device than required to meet specifications to hold the Point Setter ARM in place during surgery.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026