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Recall of Jawbone Lengthening Plate is Johnson & Johnson’s Twelfth Class-I Recall Since 2012

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The U.S. Food and Drug Administration (FDA) announced last week that Johnson & Johnson’s DePuy Synthes subsidiary recalled some lots of its Craniomaxillofacial Distraction System jawbone lengthening  plate.

The agency is concerned the Craniomaxillofacial Distraction System could cause serious injury or death in patients fitted with the devices because they may reverse direction post-operatively.  The systems are used to lengthen and/or stabilize the lower jawbone and the side of the lower jaw in pediatric and adult patients to correct congenital or post-traumatic defects of the jaw by gradually lengthening the bone, the FDA said on the agency’s website.

The recall has been classified as a Class I, the FDA’s most serious type of recall, because there is a potential for the Craniomaxillofacial Distraction System to cause serious health problems or death.

Infants have the highest risk of serious injury or death. A device retraction in a pediatric patient may result in sudden obstruction of the trachea, leading to respiratory arrest and death. Among the general population, failure of the Craniomaxillofacial Distraction System may require surgical intervention to replace the device. So far there have been 15 reports of injury associated with the use of the system, according to PRWeb.

On April 16, 2014, DePuy Synthes sent an Urgent Notice to their customers to inform them of the problem with the Craniomaxillofacial Distraction System. The notice instructed customers to remove affected lots from their stock and included instructions for returning the devices to the company.

This is J&J’s twelfth Class I-level recall since 2012, more than any other medical device manufacturer, according to

J&J is facing thousands of lawsuits related to the ASR hip implant devices manufactured by its DePuy subsidiary, and Gynecare transvaginal mesh products made by the company’s Ethicon unit.

In February 2013, a jury awarded a woman $11.1 million, including $3.35 million in compensation for her injuries. Studies reviewed by the FDA found that approximately 10 percent of women who are implanted with transvaginal mesh products will suffer from erosion within 12 months of surgery.

DePuy recalled 93,000 ASR XL hip implant devices after data from the National Joint Registry of England and Wales showed that one out of every 8 patients (12 percent to 13 percent) who were implanted with the devices had to undergo revision surgery within five years of receiving it.

A year before the recall, The New York Times reported, an executive at J&J reported in an internal e-mail that the FDA had refused to approve the ASR XL upon reviewing company studies that showed it had failed in large numbers, requiring revision surgery for many patients. J&J had insisted prior to the recall, however, that the device was safe and argued that the company’s internal studies refuted the complaints of surgeons and regulators worldwide that the ASR XL was defective. disclaimer: This article: Recall of Jawbone Lengthening Plate is Johnson & Johnson’s Twelfth Class-I Recall Since 2012 was posted on Thursday, September 4th, 2014 at 5:59 pm at and is filed under Medical Device Lawsuits.

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