Class II Recall

A situation in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or in which the probability of serious adverse health consequences is remote
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The recall was designated as a Class II recall, which is defined by the FDA as "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The FDA recently announced a Class II recall for Zimmer's Persona Trabecular Metal Tibial Plate knee implant, affecting all lots and sizes of the knee implant.
A Class II recall is initiated for a food product when consuming that product will most likely lead to short-term or non-life threatening health problems.
A Class II recall poses only a temporary health risk, or where the probability of serious adverse health consequences is remote, while Class III means that the product is not likely to cause adverse health consequences.
IARW has been informed by the California Department of Public Health that meat and poultry suppliers, distributors, brokers and processors in the state who sell products that meet the criteria for a Class I or Class II recall according to USDA guidelines must immediately notify the Department of Health and provide the department with a list of customers that have received or will receive product subject to recall.
Natus had previously communicated the problem to customers in May 2012 by issuing a Class II Recall notice, which is the FDA's mid-level health hazard classification.
Additionally, prior to the announcement of the upcoming bellwether trial, the FDA announced a Class II recall for Zimmer's Persona Trabecular Metal Tibial Plate knee implant.
A medical device organization undergoes a Class II recall, requiring the removal of approximately 400,000 affected products from the marketplace--200,000 of those out of consumers' homes.
Food and Drug Administration (FDA) has classified its voluntary recall action of the Intrepid[TM] Intervertebral Body Fusion Device as a Class II recall.
FDA issued the notice for the Class II recall on March 12th, 2015, for Zimmer's Persona Trabecular Metal Tibial Plate for all lots and sizes of the knee implant, and Lawsuit Help Center website will immediately begin assisting patients who need assistance finding a top knee replacement law firm.
This regulation categorizes product recalls into three classifications: A Class I recall means the use of the medical device could result in serious damage to health; a Class II recall implies that use of the medical device could induce temporary or recoverable health damage; and a Class III recall indicates that use of the device generally does not inflict danger to health, and other factors most likely led to the recall.
A Class II recall is one in which the malfunctioning product may cause temporary or medically reversible adverse health consequences, however the probability of serious adverse health consequences is remote.