Vertebral Body Replacement Recall: Call our Lawyers Today

The FDA has notified healthcare professionals of a Class I Recall of all lots of the Synthes USA, Ti Synex II Vertebral Body Replacement, a device used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. Reports of moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) in situ at six to fifteen months post implantation were received.

Potential adverse health issues that could be associated with this issue include neural injury, increased pain, spinal kyphosis if unrecognized, failure of supplementary fixation, and/or need for reoperation/revision surgery.

Surgeons and hospitals in possession of the subject devices must stop implanting them immediately. This product was manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009.

The recall applies to devices manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009. The devices included are:

• Part No. 04.808.001; Description: Ti Synex (TM) II Central Body 14 mm – 19 mm
• Part No. 04.808.002; Description: Ti Synex (TM) II Central Body 17 mm – 25 mm
• Part No. 04.808.003; Description: Ti Synex (TM) II Central Body 21 mm – 29 mm
• Part. No.04.808.004; Description: Ti Synex (TM) II Central Body 25 mm – 33 mm
• Part No. 04.808.005; Description: Ti Synex (TM) II Central Body 29 mm – 44 mm
• Part No. 04.808.006; Description: Ti Synex (TM) II Central Body 37 mm – 52 mm
• Part No. 04.808.007; Description: Ti Synex (TM) II Central Body 45 mm – 71 mm
• Part No. 04.808.008; Description: Ti Synex (TM) II Central Body 58 mm – 84 mm
• Part No. 04.808.009; Description: Ti Synex (TM) II Central Body 71 mm – 97 mm
• Part No. 04.808.010; Description: Ti Synex (TM) II Central Body 84 mm -110 mm
• Part No. 04.808.011; Description: Ti Synex (TM) II Central Body 97 mm -123 mm

Class 1 recalls are the FDA’s most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause adverse health consequences or death.

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