Exactech® Knee and Hip Recall Lawsuit

Patients Who Were Implanted with an Exactech Recalled Device

In August 2021, Exactech recalled its first product due to these defective plastic inserts. Now Exactech has expanded the recall to include the remaining 55,269 non-conforming Exactech Knee Ultra-High Molecular Weight Polyethylene inserts in the field, regardless of shelf life. Exactech estimates that there are approximately a total of 147,732 inserts implanted in the US since 2004 that were produced with non-conforming packaging. The Food and Drug Administration (FDA) classified the recall as a Class II recall, which occurs when consumers may experience severe health consequences of a temporary or medically reversible nature.

As part of the expanded recall, Exactech provided surgeons with a draft letter to their patients who were implanted with Exactech knee devices packaged in non-conforming bags. It was recommended that surgeons customize this letter and send it to patients implanted with non-conforming devices.

Additionally, Exactech provided patients and physicians with:

• A list of all the surgeons’ knee patients who received defective non-conforming bags;
• Frequently asked questions page available online and
• A tool on Exactech’s website that allows a patient to enter her/his implant serial number and confirm whether or not that implanted device is non-conforming.

Exactech has also published an online list of affected devices, product codes, descriptions, and serial numbers. Recalled devices include the following Exactech knee systems:

• Optetrak: 60,926 implanted units since 2004
• Optetrak Logic: 60,518 implanted units since 2004
• Truliant Knee Replacement: 24,727 implanted units since 2004

Injuries Potentially Related to the Exactech Knee Device Recalls 

The defect contained within these Exactech knee and hip devices can lead to the following injuries:

• Premature wear of the device
• Bone loss
• Disintegration of bone cells (lysis)
• Pain
• Loosening
• Component fatigue cracking/fracture
• Necessary corrective revision surgery

How Robins Kaplan Law Firm Can Help With Your Exactech Claim

Unfortunately, Exactech has not yet directly notified individuals who received the recalled knee or hip replacements. Instead, the company is relying on surgeons to inform their patients as to whether they are impacted by the defective medical devices.

Should your surgeon contact you about your device, please contact us to discuss your potential claim against the product manufacture, Exactech. You may be eligible to submit a claim if you or a loved one:

• Have an Exactech hip or knee implant, or
• Suffered side effects from the Exactech implant, or
• Received a letter or other communication from your surgeon informing you of the recall