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Synex II Vertebral Body Replacement
The U.S. Food and Drug Administration has announced a recall of Synthes USA's Synex II Vertebral Body Replacement/Central Body components used in back surgeries to help stabize the spine after injury. The FDA issued a Class I recall, meaning the device could pose an imminent health hazard.
The recall involves those devices manufactured between June 2007 and September 2009. The vertebral body replacement is a spacer used in the T1-L5 portion of the spine to replace a collapsed, damaged or unstable vertebral body due to a tumor or trauma. Loss of device height may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or the need for surgery to modify the implanted device.
The recall involves the following part numbers:
| Part Numbers | Descriptions |
|---|---|
| 04.808.001 04.808.002 04.808.003 04.808.004 04.808.005 04.808.006 04.808.007 04.808.008 04.808.009 04.808.010 04.808.011 | Ti Synex (TM) II Central Body 14 mm - 19 mm Ti Synex (TM) II Central Body 17 mm - 25 mm Ti Synex (TM) II Central Body 21 mm - 29 mm Ti Synex (TM) II Central Body 25 mm - 33 mm Ti Synex (TM) II Central Body 29 mm - 44 mm Ti Synex (TM) II Central Body 37 mm - 52 mm Ti Synex (TM) II Central Body 45 mm - 71 mm Ti Synex (TM) II Central Body 58 mm - 84 mm Ti Synex (TM) II Central Body 71 mm - 97 mm Ti Synex (TM) II Central Body 84 mm -110 mm Ti Synex (TM) II Central Body 97 mm -123 mm |
If you or someone you love had back/spinal surgery involving a vertebral body replacement device and have since suffered an injury or pain, you have valuable legal rights. Please fill out our online form, or call us toll free at 1-888-839-3775 to discuss your rights with one of the experienced defective product attorneys at our firm.
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