FDA Issues Recall of CMF Distraction System

FDA Issues Recall of CMF Distraction System

Posted By Golomb & Honik || 24-Sep-2014

The FDA has issued a recall for some Craniomaxillofacial (CMF) Distraction Systems manufactured by DePuy Synthes. The device is used to stabilize and gradually lengthen the lower jawbone in an effort to correct birth defects in infants or disfigurement in older patients due to traumatic injuries. The implant is attached to either malformed or fractured areas of the jawbone with the purpose of promoting and directing bone growth over a period of time.

The implant is comprised of two clover leaf or mesh design plates, which are threaded with screw holes and an inflexible extension arm that fastens to the two plates enabling placement accuracy.

Class I Recall

In April 2014, DePuy Synthes issued an Urgent Notice to hospitals and medical professionals requesting they inspect their inventory and remove any of the affected CMF systems after the company discovered the device posed a risk of reversing direction, thus losing distraction, after implantation.

The recall was announced on August 28, 2014 after at least fifteen reports of injury had been documented by the FDA. The action has been classified as a Class I recall, the most serious type of recall, indicating a risk of severe adverse health conditions, including death, with continued use of the implant.

Health Risks

If the CMF implant does reverse direction, patients at greatest risk of serious injury are infants, due to respiratory arrest or death brought on by abrupt obstruction of the trachea. The possibility for such dire consequences could be somewhat diminished in older patients who are capable of maintaining an open airway. However, additional surgery may be necessary to replace the faulty device.

Patients who are currently implanted with distractors should contact their healthcare providers to determine the proper course of action. Remedies will vary depending on the severity of the abnormality and the patient's age, among other factors.

How a Defective Medical Device Attorney Can Help

If you or a loved one has been injured by the DePuy Synthes CMF distraction System, you may be entitled to compensation for your current and future medical bills related to the treatment of your injury, in addition to damages for your pain and suffering. Filing a lawsuit also serves to hold the manufacturer accountable for sending faulty medical devices to market, and discourages other companies from doing the same thing.

If your child or someone you love has suffered complications or harm from the DePuy Synthes CMF Distraction System, please contact the Philadelphia product liability attorneys at Golomb & Honik for your no-cost case evaluation.

To learn more about your legal options or to schedule a free consultation call the Philadelphia product liability lawyers at Golomb & Honik today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national defective medical device lawyers at Golomb & Honik have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.

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