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