Can I still file a claim if my device has already been recalled?

A recall means a manufacturer or other firm corrected or removed a marketed device that the FDA considers to violate applicable law, often because the device is defective, presents a health risk, or both.

The FDA classifies recalls by severity, and a recall can apply to an entire product line or only to specific models, lots, or serial numbers.

Most recalls are voluntary, and a recall does not always mean the device has to be taken out of service or removed from a patient right away. The appropriate response often depends on the specific risk involved and can vary from patient to patient.

A recall alone does not settle your case

The fact that a device was recalled does not, by itself, prove that your specific implant was defective, that it caused your injury, or that the manufacturer is legally responsible for what happened. A recall may also apply to only certain models, lots, or serial numbers rather than an entire product line, so sharing a brand name with a recalled device does not establish that your particular unit was included.

• Matching your device's brand, model, lot, and serial number to the recall's affected group is often where this analysis starts
• Medical records, imaging, and any operative report from a revision or removal can document what actually happened to your implant
• The timing of your claim is a separate issue from the recall itself, and a recall issued years before or after your injury does not automatically extend or shorten your filing deadline

The individual medical and device evidence still has to connect your specific implant to the recalled condition before a claim can move forward in court.

How can The Law Offices of Sean M. Cleary help you in a defective medical device case?

Confirming whether your device falls within a recall, and connecting that recall to your medical history, is often where our review begins. Our office gathers device records, recall notices, and treatment history to determine whether a defective medical device claim exists. Contact us for a free consultation to discuss your case.