Following an FDA request, Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics launched a recall of all unused units of its customer orthopedic implants, a product line the company shut down in January.
DePuy in January announced it would discontinue its custom orthopedics division after in response to an FDA warning following an inspection of the Warsaw, Ind.-based company’s facilities.
The FDA ordered DePuy to notify surgeons that the federal watchdog agency had identified concerns with the implants, and further asked the device maker to take steps to retrieve all remaining unused devices, according to a DePuy letter sent to physicians.
DePuy has sold more than 8,300 customer units since 1999, spokeswoman Mindy Tinsley told MassDevice.com in an email today. The recall affects only unused implants, for which no number was given.
"Devices meeting the regulatory definition of a custom medical device are those which are provided by prescription at a physician’s request to meet a specific patient need and have been exempt from FDA premarket review under the Federal Food, Drug, & Cosmetic Act since 1976," according to the physician letter. "The agency has identified concerns about DePuy Orthopaedics’ interpretation of the custom device definition."
Mid-January the FDA’s Centers for Devices & Radiological Health released a letter warning DePuy that certain custom devices and components sold by the company need new PMA or 510(k) applications.
The watchdog agency detailed more than a dozen devices or device components it said lacked proper FDA clearance or which were modified in ways that merit a new 510(k) application.
"The fact that the final specifications are tailored to match a patient’s anatomy does not preclude a clinical study or submission of a marketing application for the devices," Silverman wrote.
Just days after the warning was unsealed, DePuy announced that it would permanently stop production of all custom devices, not just the dozen or so listed in the warning letter, DePuy spokeswoman Jessica Masuga confirmed with MassDevice.com at the time.
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