Recall Z-0073-2012 ยท JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
Mizuho Orthopedic Systems Inc
Mizuho OSI Modular Table System; Product Usage: For use in orthopaedic surgery to provide support to a patient.
| Date | Oct 27, 2011 (initiated Jul 29, 2011) |
| Status | Terminated |
| Reason | Reports of injury related incidents while using the Mizuho OSI Modular Table System. |
| Root cause | Use error |
| Action | Mizuho Orthopedic Systems Inc sent a "Field Advisory Notice (Recall)" letters dated July 29, 2011 to all customers using the Modular Table System via Federal Express. The Field Advisory Notice reference the devices involved and explain that there is no need to return any product or to discontinue the use. The letter provides WARNINGS and RECOMMENDATIONS for all users to consider when using the devices and request that the response form be completed as instructed in the advisory communication. The letters also recommend that awareness, training, inspection prior to use, and proper maintenanc |
| Quantity | 15,011 units |
| Distribution | Worldwide Distribution - Nationwide USA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910736 | JACKSON MULTIPURPOSE OPERATING TABLE Orthopedic Systems, Inc., May 21, 1991 |