Synthes USA is recalling all lots of the Ti Synex II Vertebral Body Replacement device. The U.S. Food & Drug Administration (FDA) has deemed the Synthes USA Ti Synex II Vertebral Body Replacement recall a Class I recall.
The Ti Synex II Vertebral Body Replacement is used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. The recall is being issued because of reports of moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) in situ occurring at six to fifteen months post implantation.
Loss of device height may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for a reoperation or an operation to modify the implanted device.
The FDA has directed that surgeons and hospitals in possession of the recalled devices stop implanting them immediately. Patients who have this recalled device and have increased pain, other symptoms, or questions should contact their surgeon.
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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