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Synthes Recalls Synex II Vertebral Body Component - FDA Classifies Voluntary Medical Device Recall as a Class I Recall
On September 14, 2009, Synthes USA announced a voluntary recall of its Synex II Vertebral Body Component. The announcement is in connection with a global recall of the Synex II Central Body components. The Synex II Vertebral Body Component is a medical 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.
The recall has been classified by the FDA as a Class I recall. This is the most serious category of recall and involves situations in which there is a reasonable probability that the recalled product will cause adverse health consequences including injury or death.
The recall of the Synex II Vertebral Body Components was brought on by reports of six adverse events where the devices failed, causing moderate to severe loss of vertebral body replacement height. Such failure can lead to increased pain, neural injury, spinal kyphosis and the need for revision surgery.
Synthes has advised physicians, hospitals and sales consultants about the recall and has provided instructions regarding the recalled device to physicians and patients. Customers have been requested to return unused inventory and to return all surgically removed devices for evaluation.
In the event that you or a have been effected by this recall, you should seek the advice of the medical device attorneys at the Kansas City Accident Injury Attorneys in order to determine whether you may be able to make claim for any injuries or damages you have suffered.
Download Our FREE Medical Malpractice Book
Individuals who are the subject of a recalled implanted medical device often have many immediate questions. Answers to some of your most important questions can be found right here on this website. For more information, you should also download our FREE book, "The Truth About Medical Malpractice Claims, The Ultimate Guide to Medical Malpractice Cases in Missouri and Kansas."
Contact Kansas City Accident Injury Attorneys at (816) 471-5111 for a FREE CASE EVALUATION
The lawyers at Kansas City Accident Injury Attorneys have been representing victims of medical malpractice including the implantation of defective medical devices for more than 15 years. We are proud to offer FREE consultation with no obligation for the potential victims of medical malpractice and their families. If you believe that you or a loved one has been injured due to the implantation of a defective medical device, contact our experienced team of lawyers at (816) 471-5111 and we will evaluate your case for free. If we determine that your case has merit, we will fight aggressively and tirelessly to obtain the compensation that your family deserves for your injuries. We understand that defective medical device injuries can be devastating and our Missouri and Kansas defective medical device injury law firm will bring more than 15 years of experience and knowledge and compassion to your case.
Kansas City Accident Injury Attorneys
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