Class I Recall of Vertebral Replacement by Synthes USA
The FDA and Synthes USA have declared a class I recall of the Ti Synex II Vertebral Body Replacement (VBR) product. This device is used to replace damaged T1 – L5 vertebral material during replacement surgery. The FDA received six adverse event reports that lead to the recall. The reports indicated a failure of the medical device from 6 to 15 months after placement. The failure is described as a moderate to severe loss of vertebral height. Loss of height in the device may potentially lead to the following medical issues:
- Neural injury
- Increased pain
- Spinal kyphosis
- Reoperation or revision surgery
Synthes advises hospitals and physicians currently in possession of all lots of part numbers 04.808.001-011, Synex II Central Body, Titanium to stop implanting immediately. To find out more about returning this product, please contact Synthes USA at 1 (800) 620-7025, ext. 5375.
Patients who received Synex II implants manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009, should be closely monitored using x-rays and pain assessments to ensure no loss of vertebral height. Changes in the level of pain or loss of height may indicate a potential failure of the device.
To mitigate its liability for a defective medical device, the manufacturer issued this recall. Class I recalls are the most serious type of recall, indicating potentially serious medical problems may occur with the use of the product. Undesirable events related to this product should be reported to the FDA’s MedWatch Adverse Events Reporting program online at http://www.fda.gov/medwatch/report.htm.
If you or a loved one has suffered from a failure of this device after surgery, please contact the qualified product liability attorneys at Schlichter, Bogard & Denton, LLP to discuss your legal options.