DePuy Jaw Implant (Synthes Craniomaxillofacial Distraction System)
Recall Number: #Z-2148-2014
Date Published: August 20, 2014
Manufacturer: Johnson & Johnson
Obstruction of the Trachea
Summary by USRecalls.org
The FDA and DePuy has issued the most serious Class 1 recall of their Synthes Craniomaxillofacial (CMF) Distraction System. This is an implant used to lengthen and/or stabilize the jawbone in infants, children, and adult to either correct a birth defect of after a trauma. The device has been found to fail and reverse direction causing the implant to "lose the desired distraction distance" after surgery. In cases where the device fails in an infants patient, it can cause an obstruction of the trachea leading to respitory arrest and death. In cases of older children and adults the obstruction of the trachea may be reversed medically.
FDA Official Description
DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they may reverse post-operatively. The firm, DePuy Synthes, sent "Urgent Notice: Medical Device Recall" letters dated April 16, 2014 to affected customers. The letter identified the affected product, reason for recall, potential patient impact, mitigation steps for patients with distractors currently implanted and actions to be taken. Customers were instructed to review inventory, immediately remove the affected lots from stock, complete verification section of the letter and return the affected product.
DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies
Also called an External Mandibular Fixator And/Or Distractor and a Bone Plate.
Manufacturing Dates: April 20, 2009 through April 15, 2011
cDistribution Dates: November 3, 2009 to April 14, 2014
What do I do next?
All patient's who have received this recalled device may want to consult with a physician. In all patients if failure of the device occurs it may result in surgery to replace the recalled device. If you have any question you can contact DePuy Synthes Customer Support at 1-800- 479-6328, Monday – Friday, 9:00 a.m. to 8:00 p.m. Eastern Time.