Synthes USA of Westchester, Pa., has recalled all lots of a device used to replace collapsed, damaged, or unstable vertebral bodies in the spine, the FDA said.
The Class I recall affects eleven sizes of the device, called the Ti Synex II Vertebral Body Replacement, ranging from 14-19 to 97-123 mm. They are used in the T1 to L5 region of the spine, typically in patients with spinal tumors or fractures.
Devices distributed from July 2, 2007, through Sept. 8, 2009, are prone to failure of the central body component, resulting in loss of device height, the FDA said.
When this occurs, patients may suffer nerve injury, increased pain, spinal compression fracture, or failure of additional fixation, according to the FDA. Some patients may need additional surgeries to correct these problems and/or to modify the implanted device.
Hospitals and surgeons should stop implanting the devices immediately, the FDA said.
Synthes USA began notifying hospitals and sales consultants about the recall in late September, with a follow-up letter sent to physicians this week.