Synthes Synex II Central Body Components
Motley Rice is no longer accepting cases of patients who have suffered injury or complications related to Synthes Synex II Central Body Components. The FDA issued a Class I recall on September 14, 2009 involving all lots of the Synthes USA, Ti Synex II® Vertebral Body Replacement, a device inserted in the T1-L5 portion of the spine to replace a collapsed, damaged or unstable vertebral body due to a tumor or trauma (fracture).
Synex II Central Body Components Side Effects
The Synthes USA, Ti Synex II Vertebral Body Replacement is allegedly prone to failure of its central body component, a malfunction that can result in loss of device height. Reports of complications from patients have been received at six to fifteen months post-implantation and include the following:
- Failure of additional fixation
- Increased pain
- Need for correctional surgery or surgery to modify the implanted device
- Nerve injury
- Spinal compression fracture
Class I Recall of Synex II Central Body Components
Synthes USA, a leading global medical device company, announced the Class I recall in 2009. This product was manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009. Class I recalls are the most serious type of recall and involve products whose use may cause serious health consequences or death.
On September 23, 2009, Synthes USA notified hospitals and sales consultants about the recall by mail and advised surgeons and hospitals in possession of the recalled device to immediately stop implanting them. On November 9, 2009, the company also sent physicians a letter for patients informing them about the serious nature of a class I recall.
The recall involves the following:
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