FDA Recalls Mizuho Surgical Tables

Emma Hitt, PhD

Disclosures

November 10, 2011

November 10, 2011 — The US Food and Drug Administration (FDA) has issued a class I recall of Mizuho OSI Modular Table Systems because of the potential for incorrect removal of supporting T pins that could cause the patient to fall to the floor.

The tables are used for patient positioning during various orthopaedic trauma, thoracic, and spinal surgery procedures.

According to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program, the incorrect removal of the T-pins that support the bottom base, instead of the T-pins that support the top, may result in patients falling to the floor.

"Another potential concern is unexpected movement/tilting of the table which may result in unanticipated movement and/or patient falls during surgery," which may result in injury or death, the FDA notes.

Previously, on July 29, 2011, the manufacturer issued a field advisory notice to all personnel involved in the use and/or set up of the OSI Modular Table Systems. The notice described how to properly use the table so that no accidents would happen, which included verifying the number of T-pins to confirm the stability of the table top.

The current recall was initiated on October 26, 2011, and involves OSI Modular Table Systems, including Modular Bases, Jackson Spinal, Imaging, Lateral, and Orthopedic Tops. All recalled products were manufactured and distributed from January 1992 to June 2011.

Specific model numbers of the units involved in the recall are listed on the FDA Web site.

FDA class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Questions should be directed to Mizuho on the company's toll-free hotline at 1-800-777-4674, Monday through Friday, from 9:00 am to 5 pm Pacific Time.

Adverse events related to these products should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....