After receiving 15 reports of injury, DePuy Synthes has issued a Class I recall for the Craniomaxillofacial Distraction System, a device used to lengthen jaw bones, because it can reverse direction, obstruct the trachea, and cause respiratory arrest and death in infants.
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The device is surgically implanted and attached to the lower jaw (mandible), where it provides stabilization and lengthens the bones until they are at the appropriate location. It is designed for use in infants with birth defects, children, and adults who have traumatic injuries to the jaw.
Other names for the device:
- External Mandibular Fixator
- Bone plate
Class I Recall
The U.S. Food and Drug Administration (FDA) issued a Class I recall for the Craniomaxillofacial (CMF) Distraction System on August 28, 2014.
What is the problem?
Unfortunately, the device can reverse direction after surgery. This could cause the jaw to lose the desired distraction distance. The risk is especially serious in infants, who are at risk of life-threatening injuries:
“Infants are at the highest risk for injury if the device fails because sudden obstruction of the trachea can occur. This could lead to respiratory arrest, and result in death.”
Older children or adults are not as likely to develop life-threatening side effects because a defective device is unlikely to block the trachea. However, anyone who is implanted with this device is at risk of needing additional surgery to remove and replace the implant.
Urgent Medical Device Recall
DePuy Synthes, a subsidiary of Johnson & Johnson, notified their customers of the recall in April 2014 with an “Urgent Medical Device Recall” notice. Customers were informed of the problem and instructed to return the devices. The recall affects products that were sold between November 2009 and April 2014.
Click here for a list of affected lot numbers, products, and part numbers.
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