The FDA slapped Class I status on the recall of Mizuho Orthopedic Systems Inc.’s modular table system after reports surfaced of patients falling to the floor during procedures.
The tables are designed to allow physicians to position patients for a variety of orthopedic trauma, thoracic, and spinal surgery procedures, according to the federal watchdog agency.
"The incorrect removal of the T-pins that support the bottom base, instead of the T-pins that support the top, may result in the lower table top and patient falling to the floor," according to the FDA. "Another potential concern is unexpected movement/tilting of the table which may result in unanticipated movement and/or patient falls during surgery. Both of the above may result in serious injury or death."
Mizuho issued a field advisory notice July 29 to tell health care providers how to safely set up and operate the tables, including a verification count of the T-pins.
"While FDA agrees that the factors identified by the firm may have contributed to some reported failures, FDA is concerned that the firm has not identified all factors contributing to these events," according to the agency. "Questions should be directed to Mizuho on their toll-free hotline at 1-800-777-4674, Monday through Friday from 9:00 am to 5 pm, Pacific Time."