Synthes USA, Ti Synex II Vertebral Body Replacement (VBR) Lots Numbers

Lawyers Mark Zamora and Rob Bunch are investigating these claims, and you can reach them at 404-451-7781 and 888422-2882.

 

Here is the information on the recalled Lots:

 

Ti Synex II Vertebral Body Replacement (VBR)

 

This recall involves part numbers 04.808.001-11, Synex II Central Body, Titanium (all lots).

 

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

 

This product was manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009.
Use: This device is a vertebral body replacement device that is used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body due to a tumor or trauma (that is, a fracture).
   
   

Adverse Event Reporting is done here:

 

www.fda.gov/Safety/MedWatch/default.htm

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