We are no longer accepting cases for this medical device.

Attorneys Tim Edwards and Ed Wallis are currently investigating cases and offering free case evaluations to patients who received a Synthes USA, Ti Synex II Vertebral Body Replacement. An FDA Class I Recall was issued on September 14, 2009 involving 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 due to tumor or trauma (fracture).

The reason for the FDA recall is that the loss of device height may result in adverse health issues that include:

• failure of additional fixation
• increased pain
• need for a reoperation or an operation to modify the implanted device
• nerve injury
• spinal compression fracture

You can access the FDA recall information by CLICKING HERE. Reports of complication have been received at six to fifteen months post implantation.  The recall involves the following:

Part Numbers (Descriptions)

• 04.808.001 ( Ti Synex (TM) II Central Body 14 mm – 19 mm)
• 04.808.002 (Ti Synex (TM) II Central Body 17 mm – 25 mm)
• 04.808.003 (Ti Synex (TM) II Central Body 21 mm – 29 mm)
• 04.808.004 (Ti Synex (TM) II Central Body 25 mm – 33 mm)
• 04.808.005 (Ti Synex (TM) II Central Body 29 mm – 44 mm)
• 04.808.006 (Ti Synex (TM) II Central Body 37 mm – 52 mm)
• 04.808.007 (Ti Synex (TM) II Central Body 45 mm – 71 mm)
• 04.808.008 (Ti Synex (TM) II Central Body 58 mm – 84 mm)
• 04.808.009 (Ti Synex (TM) II Central Body 71 mm – 97 mm)
• 04.808.010 (Ti Synex (TM) II Central Body 84 mm -110 mm)
• 04.808.011  (Ti Synex (TM) II Central Body 97 mm -123 mm)

The Synthes USA, Ti Synex II Vertebral Body Replacement was manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009.

On September 23, 2009, Synthes USA notified hospitals and sales consultants about this recall by mail. Surgeons and hospitals in possession of the subject devices were advised by the company to stop implanting them immediately. On November 9, 2009, the company sent physicians a follow up letter for their patients advising that 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.

Damages

If you or a loved one has been injured, recovery is possible for medical bills, pain and suffering, lost income (past and future), and more. Please call today to speak to Tim Edwards or Ed Wallis at 901.527.2125 for more information.

No Recovery, No Fee

Generally speaking, we take cases on a contingent basis. That means that there is generally no cost to you unless we are able to recover a settlement or judgment on your behalf. So, unless your case is resolved by trial, arbitration, settlement, or other resolution, you generally do not have to pay any attorney fees to us, or pay any costs. Litigation costs include filing fees, court reporter fees for deposition, copying costs, experts, and travel. Litigation costs are paid by our firm so you don’t have to have cash to pursue justice against Advanced Bionics. If there is a recovery, we are reimbursed our fronting of litigation costs out of any damages you are awarded. So, in a sense, you do not need cash up front to hire us as your lawyer to pursue a claim for personal injuries, emotional injuries, lost business or property damage.

About us

Mr. Edwards and Mr. Wallis are currently representing injured children and adults on an international level for a failed medical device.  Both have represented clients, filed lawsuits and appeared in courts around the country to protect the rights of the injured including for the Advanced Bionics HiRes90k cochlear implant, the transvaginal mesh device, the Heartmate II, Composix® Kugel® Mesh Hernia Repair Patch, NexStent®, Medtronic Sprint Fidelis® Defibrillator Leads, and the Zimmer Durom® Cup Hip Replacement.

You can read more about Mr. Edwards and Mr. Wallis in the ABOUT US section of this website, and you should feel free to please contact us today for a free case evaluation.

Contacting us

Tim Edwards
Ed Wallis
Glassman Edwards Wade & Wyatt
26 N. 2nd Street
Memphis, TN 38103
(901) 527-2125
(901) 275-0600 (after hours / weekends)
EMAIL BY CLICKING HERE

Or please fill out this form, and we will immediately contact you: