DePuy Synthes Craniomaxillofacial Distraction System - May Reverse Directions After Surgery
Recall Class: Class I
Date Recall Initiated: April 16, 2014
Product: The DePuy Synthes Craniomaxillofacial (CMF) 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
Distribution Dates: November 3, 2009 to April 14, 2014
Use: The DePuy Synthes Craniomaxillofacial (CMF) Distraction 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).
1302 Wrights Lane East
West Chester, PA 19380
Reason for Recall: DePuy Synthes is recalling certain lots of the Craniomaxillofacial Distraction System because the device may reverse direction and lose the desired distraction distance after surgery.
- 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.
- Children or 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.
- In all patient populations, failure of the device may result in the need for surgical intervention to replace the failed device.
There have been 15 reports of injury associated with the use of this device.
Public Contact: Customers who have questions about this recall may contact DePuy Synthes Customer Support at 1-800- 479-6328, Monday – Friday, 9:00 a.m. to 8:00 p.m. Eastern Time or the sales consultant.
FDA District: Philadelphia District Office
More Information about this Recall:
On April 16, 2014, DePuy Synthes sent an Urgent Notice to their customers. The notice identified the problem, affected products and tells customer 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.
About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.