By Debra Sherman
Feb 22 (Reuters) - The U.S. Food and Drug Administration on
Friday said it has notified healthcare professionals of a Class
I recall, the most serious type, of an orthopedic device made by
Johnson & Johnson.
The device, called LPS Diaphyseal Sleeve, is used in
reconstructive knee surgery. It was recalled because of the
potential for fractures, the FDA said.
The agency said it has received 10 reports of incidents in
which the device has malfunctioned.
The affected devices were manufactured by Depuy, J&J's
orthopedic unit, from 2008 to July 20, 2012.
A fracture in the sleeve at the joint of it could lead to
loss of function or loss of limb, infection, compromised soft
tissue or death, the FDA said.
The FDA said the company is not recommending revision or
additional follow up in the absence of symptoms of patients with
this implanted device.
J&J's Depuy is currently defending itself against a slew of
lawsuits over its hip implants.
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