Is my Implant Recalled?

We receive calls from concerned patients or family members inquiring if their implant has been recalled. The information enclosed in this section can help you feel more confident in the entire recall process and place your concerns at ease.

Most recalls, do not mean that you will need further surgery. In fact, if your joint is not having symptoms, you may only need standard monitoring such as yearly x-rays and a visit with your surgeon.

When a device or even an injectable material is recalled by the FDA (Federal Drug Agency), a strict and thorough recall notification process is initiated. There are at least two notifications provided to ensure that you are properly and promptly notified. This process is similar to a recall on your automobile, but with stricter guidelines. Many times, there are only certain lots of implants recalled.Each implant has a traceable serial and lot number assigned and this becomes part of your hospital record. Thus, when you hear that a specific implant company has a recall, this does not mean that your specific implant is involved in this recall.

The manufacture of the implant has a duty to contact two people involved in a specific recall. The first is you, the patient. You will receive a certified letter notifying you of the recall and normally a suggestion to seek medical evaluation.

The second letter will be sent to the surgeon who placed the implant. Our office policy is to make an attempt to notify patients as soon as possible of any recall and ask them to report in for medical evaluation. So, you can rest assure if a real recall occurs, you will be notified by either the manufacture and/or the surgeon.

One mistake is to go to the internet and search for a recall on your implant    There are many web sites designed to tell everyone and anyone that their implant has been recalled.  Normally, these misleading sites obtain information from you and refer you to a local lawyer.This only leads to frustration and anxiety.  So, before you search for a recall on your implant, understand that you will be contacted first.    There is little need to search for a recall.

If you are having symptoms from your replaced joint, contact your surgeon for a thorough evaluation and x-rays.   If you still have concerns, you can go to the following FDA web site for official information on recalled implants:

official information on recalled implants

If you would like to learn more, the FDA has a few webinars produced to walk you through the recall process at :

Fda.Gov Webinar

Recalls can be a scary thought, but there are numerous processes set up to ensure you are notified in a timely manner.

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Important: Please include non-medical questions and correspondence only.