FDA Announces Class II Recall of Zimmer Knee Implant.
M2 PHARMA-April 23, 2015-FDA Announces Class II Recall of Zimmer Knee Implant
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The FDA has announced a Class II recall for US-based medical device maker Zimmer's Persona Trabecular Metal Tibial Plate knee implant, according to lawsuit settlement news reporting company MT Services LLC.
This recall affects all lots and sizes of the knee implant, affecting all 11,658 devices that were recalled, according to the FDA's website.
Also, according to an announcement made by the FDA, they said Zimmer Inc. initiated a voluntary recall of their Persona Trabecular Metal Tibial after there was an increase in complaints of loosening and radiolucent lines.
All sizes and lots of the affected devices will be removed from the market and will no longer be distributed. A Class II Recall occurs when a product can "cause temporary or medically reversible adverse health consequences.
Patients who have been implanted with the Persona Trabecular Metal Tibial Plate face the risk of their tibial component loosening. Indications of this complication include radiolucent lines on imaging tests, and such loosening may cause pain and issues with mobility, often requiring the patient to have an additional surgery.
Prior to this latest Class II Recall, Zimmer Inc. issued voluntary recalls for its metal-on-metal hip device the Durom Cup, in 2008 and another recall for the NexGen MIS Tibial Components in 2010.
Those recalls led to lawsuits which are pending in a federal multidistrict litigation (In Re: Zimmer Durom Hip Cup Products Liability Litigation, MDL No. 2158) and Illinois (In Re: Zimmer NexGen Knee Implant Products Liability Litigation, MDL No. 2272).
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|Date:||Apr 23, 2015|
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