Vertebrae Replacement Implants Recall Issued Due to Failure Risk

The FDA announced a Class I recall on Thursday for all lots of the Synthes USA, Ti Synex II Vertebral Body Replacement (VBR), which are used to replace damaged vertebrae.

The Vertebral Body Replacement recall was issued after the manufacturer received six reports of incidents where the devices collapsed inside of patients’ bodies only months after being implanted. Class I recalls are the most serious type of recalls, and are issued in situations where there is a reasonable probability that use of the recalled product will cause serious injury or death.

The devices, manufactured by Synthes USA of West Chester, Pennsylvania, are designed to replace a collapsed, damaged or unstable vertebral body which has been affected by a tumor or fracture.

Adverse event reports suggest that the central component of the replacements may fail and collapse. This has been found to occur between six and 15 months after implantation, according to the FDA announcement. The agency warns that the collapses could cause neural injury, increased pain, spinal kyphosis if unrecognized, failure of supplementary fixation, and can potentially lead to a need for corrective surgery to replace or modify the device.

The recall of the Ti Synex II Vertebral Body Replacement includes all lots with the titanium Synex II central body, with part numbers 04.808.001-11. The devices were manufactured from June 8, 2007 through September 9, 2009, and were distributed between July 2, 2007 and September 8, 2009.

Synthes USA alerted hospitals and sales consultants of the recall by mail on September 23, 2009 and provided instructions on how to return products still in their inventory and asked for them to return devices that have been surgically removed for evaluation. The company sent a follow-up letter to physicians to instruct their patients on November 9.

The company also recommends that physicians add additional annual monitoring for patients that have already had the devices implanted, and should check the devices through radiographs and pain assessment.