This article is more than 5 years old. Information may no longer be current.
FDA classifies recalled vertebral components as ‘imminent hazard’
Click Here to Manage Email Alerts
The U.S. Food and Drug Administration has classified a recall of Synthes Synex II Central Body components as Class I, meaning the product could impose an imminent hazard to health in patients.
The recall involves part numbers 04.808.001-011, Synex II Central Body, Titanium (all lots).
The FDA notification relates to a global voluntary recall of Synex II Central Body components on Sept. 14, 2009, which was initiated after receiving six adverse event reports and revised on Nov. 9. The reports included moderate to severe loss of vertebral body replacement height caused by failure of the central body component 6-15 months post-implantation.
According to the FDA, loss of device height may result in nerve injury, increased pain, spinal compression fracture and failure of additional fixation. Furthermore, additional surgical procedures may be necessary to modify the implanted device.
Hospitals and sales consultants were informed of the recall through the mail. The notification included identification of the recalled product, a description of the issue and the potential health ramifications that could occur.
“Synthes advises that surgeons and hospitals in possession of the subject devices must stop implanting them immediately,” the company said in a release. “Physicians should contact Synthes for return instructions.”
Synthes also recommended that radiographs and pain assessment be used to annually monitor implanted patients, as radiographic changes and an increase in pain or other symptoms may be indicators of device failure. Patients experiencing an increase in pain should contact their surgeons.
Additionally, Synthes has stated their intent to provide additional notification and instruction to patients through their physicians.
For more information:Physicians with questions related to Synthes Synex II Central Body components should contact Synthes at 1-(800)-620-7025, ext. 5375.
Any adverse reactions or events experienced with the use of the Synthes Synex II Central Body devices should be reported to Synthes at 1-(800)-752-0128; e-mail: ComplaintUnit@synthes.com.
- Reference:
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm190300.htm