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

Vertebral Body Replacement Recall

 

Attorneys Mark Zamora at 877-574-6454 and Rob Bunch at 888-422-2882 are investigating links between this recall and injuries

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)  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 involves part numbers 04.808.001-011, Synex II Central Body, Titanium (all lots).

 

Total Body Formula Recall

My office is investigating the makers of Total Body Formula, a supplement  that was recently recalled.

The U.S. Food and Drug Administration is advising consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.

The Total Body Formula products are sold in eight-ounce and 32-ounce plastic bottles. The Total Body Mega Formula is sold in 32-ounce plastic bottles. Both products are distributed by Total Body Essential Nutrition of Atlanta. The company is the sole distributor of the products and has voluntarily recalled Total Body Formula in the flavors of Tropical Orange and Peach Nectar and Total Body Mega Formula in Orange/Tangerine flavor.

On May  1, 2008,  The U.S. Food and Drug Administration’s final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula” has detected hazardous amounts of chromium.

FDA analysis of the products found high levels of chromium among other items. The samples contained up to 3,426 micrograms of chromium for the recommended serving (17 times the recommended intake). The recommended chromium intake for an adult ranges from 35 to 45 micrograms per day.

Excessive consumption of chromium can cause fatigue, muscle cramps, hyperactivity, hypoglycemia, renal failure and liver toxicity. Excessive chromium intake also can interfere with certain medications.

  In Georgia I have filed one lawsuit (not a class action) because a client claims she was hurt by this product.





Mark Zamora, mzamoralaw@yahoo.com