FDA Issues Class 1 Recall of Jaw Implants

Johnson & Johnson Jaw Implant Recall

The FDA announced on August 28, 2014 that Johnson & Johnson is recalling the DePuy Synthes Craniomaxillofacial (CMF) Distraction System, which is a long name for a Jaw Implant intended to correct jaw defects. The device is used in adults as well as pediatric patients to stabilize the lower jawbone by gradually lengthening the bone.

This is a Class 1 Recall – The Most Serious

Class 1 recalls involve a situation whereby there is a reasonable probability that the product would cause serious adverse effects or even death. There have been 15 injury reports attributed to using this device.

Reason for The Jaw Implant Recall

Certain lots are being recalled due to findings that the device may reverse direction after surgery, losing the intended distraction distance. Infants are at an especially high risk due to the possibility of sudden obstruction or blockage of the trachea, leading to respiratory arrest and possibly death.

Additional surgery is required for all patient groups to replace or remove a defective medical device.

FDA Recall Notice:

Pennsylvania Recall Lawyers

Handler Henning and Rosenberg has been helping people injured in Pennsylvania since 1922. Our experienced recall attorneys know what steps to take in order to get your lawsuit through courts in a timely manner. Our law firm offers a free case evaluation to get you started right away.

If you or a loved one has been injured by a defective or recalled product, please contact our law firm today. You have rights and may be entitled to compensation for your injuries.


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