Device Recalls

A recall is a method of removing or correcting marketed products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall does not include a market withdrawal or a stock recovery (removal of un-marketed devices under the manufacturers' control). Medical device recalls are usually conducted by the manufacturer voluntarily using 21 CFR 7, to protect public health. However, if a manufacturer fails to report a malfunctioning device or initiate its recall, the FDA can issue a recall order under 21 CFR 810 and start legal action against the manufacturer.

Medical device recalls may result from manufacturing defects, labeling deficiencies, failure to meet premarketing requirements [PMA, 510(k)], packaging defects or other nonconformance problems. Recalls are of different classes depending on the relative degree of health hazard they pose to the user, class I posing the most hazard.
Class I - reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Class II - remote probability that the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Class III - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

A manufacturing firm may decide of its own volition and under any circumstances to remove or correct a distributed product. A firm that does so because it believes the product to be violative is requested to notify immediately the appropriate FDA District Office. Such removal or correction will be considered a recall only if the FDA regards the product as involving a violation that is subject to legal action, e.g., seizure.

When a device is found to be in violation of the FDA regulations, it is first subject to a health hazard evaluation by the FDA. Data evaluation is done to detect if the device has caused any diseases or injuries during use, or can contribute to other clinical conditions. Various assessments are conducted to evaluate
* hazards in all segments of population;
* degree of seriousness of the hazard in the exposed population;
* likelihood of hazard occurrence; and
* consequences of the potential hazard.
Based on these results and other evaluations, the FDA assigns a Recall Class to the device being evaluated.

Once the device is assigned for recall, the recall firm develops a recall strategy based on the heath hazard evaluation. The recall firm in most cases is the manufacturer of the device. The recall strategy determines the
* Depth of Recall - level of distribution chain up to which recall is to extend. Can be user level, retail level or wholesale level.
* Public Warning - to alert the public of the violative device being recalled.
* Effectiveness Checks - to verify that all consignees have received notification about the recall and have taken appropriate action.
The recalling firm is to submit periodic recall status reports to the appropriate FDA district office. The FDA assesses the progress of the recall through these reports an their frequency is determined by the relative urgency of the recall and will be specified by the FDA for each recall case. A recalling firm may request termination of its recall based on its progress. A recall will be terminated when FDA determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product.