DePuy Synthes is recalling its Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies) because infants are in danger of dying due to the failure of the device.
The system, also called an External Mandibular Fixator and/or Distractor and Bone Plate, is being recalled because the device may reverse direction and lose the desired distraction distance after surgery.
Infants at Highest Risk
According to an August 28, 2014 FDA posting, infants are at the highest risk for injury because sudden obstruction of the trachea can occur. This could lead to respiratory arrest, and result in death. Children and adults with the ability to maintain an open airway are at less risk for serious injury because failure of the device would not result in tracheal obstruction and could be medically reversible.
The FDA says in all patient populations, failure of the device may result in the need for surgical intervention to replace the failed device.
Fifteen reports of injury have been associated with the device.
The system is an implant used to lengthen and/or stabilize the lower jawbone (mandibular body) and the side of the lower jaw (ramus). This device is used in pediatric and adult patients to correct birth (congenital) or post-traumatic defects of the jaw by gradually lengthening the bone (distraction).
April 2014 Urgent Notice
DePuy Synthes sent out an Urgent Notice to customers on April 16, 2014, and told customers to:
- Review their inventory and remove affected lots from stock
- Call DePuy Synthes at 1-800-479-6329 for a return authorization number
- Complete and return the verification in the letter included with the notice
Report Adverse Events to FDA
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Here is a link to the Urgent Notice to identify lot numbers.
