Johnson & Johnson is recalling some lots of its implant used to correct defects of the jaw, following more than a dozen cases of injury.
The device, used to correct birth or post-traumatic jaw defects by gradually lengthening the bone, is being recalled by JNJ unit DePuy Synthes as it may reverse after surgery.
In such cases, patients may require surgical intervention to replace the failed device.
Infants are at the highest risk for injury if the device, Craniomaxillofacial Distraction System, fails because sudden obstruction of the trachea leading to respiratory arrest and death, the U.S. Food and Drug Administration said.
The agency said on Thursday the recall was classified as the most serious, Class 1 type, where there is a probability that use of the product will cause serious health problems or death.
DePuy in April had sent its customers a notice flagging the issue — requesting them to remove affected lots from their stock.