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Ti Synex II Vertebral Body Replacement Lawyer
Synthes USA Ti Synex II Vertebral Body Replacement
Recall Class:
Class I
Date Recall
Initiated:
September 14, 2009
Product:
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).
Recalling Firm:
Synthes USA
1302 Wrights Lane East
West Chester, Pennsylvania 19380-3417
Reason for Recall:
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.
FDA Comments:
Hospitals and surgeons that have these recalled devices must stop implanting them immediately.
On September 23, 2009, the company notified hospitals and sales consultants about this recall by mail. The company:
identified the recalled product
described the problem and potential health effects
provided instructions to their customers to return all products in
their inventory and all surgically removed devices for evaluation.
notified and provided instructions to physicians and patients (through their physicians)
On November 09, 2009, the company sent physicians a follow up letter for their patients.
Class 1 recalls are the 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.
CALL NOW 1-866-374-0338
Call us immediately if you or a loved one has been diagnosed with a defective Synthes USA Ti Synex II Vertebral Body Replacement! You may be entitled to monetary compensation from the manufacturer.
Get your free, no obligation claim review by a lawyer today.
Call us at toll free 1-866-374-0338, or
use the Free Claim Evaluation form to your right, or
click on Live Support on the right of this page.
We have represented clients in every state and helped thousands of injured clients nationwide make recoveries for their injuries. We are ready to help you! Our clients are never at risk of paying any fees, expenses, or costs out of pocket. All fees costs and expenses are paid only out of any recovery we make for you.
Do not delay. Contact us now to find out if we can help. The claim evaluation is free. All claims have strict time limitations which will bar any recovery you or your loved may be entitled if the claim is not brought on time.
Ti Synex II Vertebral Body Replacement Lawyer 
