Another Johnson & Johnson Medical Device Recall is Deemed a Class I by Federal Regulators, Parker Waichman LLP Comments

Share Article

A Class I recall designation by the FDA indicates that use of the recalled medical device may potentially lead to serious adverse reactions or death.

News Image
“We will be following FDA announcements involving the DePuy Synthes Craniomaxillofacial Distraction System and will continue to advise patients, potential patients, and health care providers regarding these matters,” said Gary Falkowitz.

Parker Waichman LLP, a national law firm that has long been dedicated to protecting the rights of victims who have been injured due to medical devices, comments on a recall issued by DePuy Synthes of its Craniomaxillofacial Distraction System. Federal regulators recently deemed the matter a Class I recall, the most serious designation made by the U.S. Food and Drug Administration(FDA). The agency announced the Class I designation on August 28, 2014.

According to the FDA announcement, DePuy Synthes, a unit of Johnson & Johnson, indicated that the DePuy Synthes Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies) may reverse direction and lose what is known as the “desired distraction distance” following surgery. The device is also known as an External Mandibular Fixator and/or Distractor and a Bone Plate.

Parker Waichman explains that, although the FDA does not typically issue recalls, it does often announce when a manufacturer recalls a product, drug, or, in this case, a medical device. When the FDA announces a recall, the agency will typically include a recall class designation. The Class I designation is considered the agency’s most serious and the designation that is most closely associated with serious injury or death.

The notification indicated that babies are at the greatest risk for injury should the device fail. Device failure in infants may lead to sudden tracheal obstruction, which may then cause respiratory arrest and death. Failure in any population group may require surgery to replace the failed device. To date, 15 reports of injury have been tied to the recalled DePuy Synthes CMF Distraction System.

According to Parker Waichman LLP, medical devices are often critical in the saving of lives and in improving lives; however, should a medical device have a faulty or defective design, and that design inhibits the way in which a medical device is meant to operate, then the device may potentially worsen a patient’s condition or lead to other adverse health effects. When this occurs, the device typically requires removal or adjustment. This becomes very challenging when a device has been implanted within a patient’s body. When an implantable medical device is found to be defective and causing, or potentially causing, harm to a patient, surgeries known as “revision” surgeries are required. In many cases, multiple revision surgeries are needed to resolve the problem with the implanted medical device. Also, in many cases, revision surgeries may not fully resolve the issue and the patient’s condition, due to a defective medical device, may be permanently worsened, leading to life-long injuries.

The DePuy Synthes CMF Distraction System is an implant that lengthens and/or stabilizes the mandibular body (the lower jawbone) and the ramus (the side of the lower jaw) and is used to correct congenital defects or defects caused by trauma, according to the agency. Used in patients of all ages, the device is used for bone distraction (gradual lengthening).

Parker Waichman LLP will continue to monitor the recall activities related to the DePuy Synthes CMF Distraction System, including reports of adverse reactions or deaths tied to this medical device.

According to another FDA posting, on April 16, 2014, DePuy Synthes sent an Urgent Notice to their customers concerning the defective jaw stabilizing system and advising that inventory of the defective device should be removed from stock.

This recall is the 12th recall issued by Johnson & Johnson since 2012 that has been deemed a Class I by the FDA. This means that Johnson & Johnson has the highest number of recalls involving medical devices deemed Class I recalls, according to an August 28, 2014 report issued by QMED.

“We will be following FDA announcements involving the DePuy Synthes Craniomaxillofacial Distraction System and will continue to advise patients, potential patients, and health care providers regarding these matters,” said Gary Falkowitz, Managing Attorney for Parker Waichman LLP.

When a medical device is found to be defective—and this may occur immediately or with the passage of time—it is the medical device maker’s responsibility to advise the agency and the public about the product’s flaw and related risks, Parker Waichman LLP noted.

Parker Waichman LLP offers free legal consultations to victims of injuries allegedly caused by medical devices. If you or a loved one experienced injuries as a result of the a procedure involving the DePuy Synthes Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies), please contact the Firm at its http:// Medical Device page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).

Share article on socal media or email:

View article via:

Pdf Print

Contact Author

Gary Falkowitz
Follow us on
Visit website