On February 7, 2022 Exactech, Inc, headquartered in Gainesville, Florida, issued a voluntary recall of its popular Exactech total ankle replacement that was manufactured between the years of 2017 and 2022. The Exactech ankle recall is centered around one component and insert of the ankle replacement device.
Why is the Exactech Ankle Replacement Being Recalled?
According to the Exactech, Inc.
“During a recent review of its ankle implant manufacturing process, Exactech learned that one of the packaging layers for the plastic insert has been out of specification and may allow oxygen from the air to diffuse into this plastic insert prior to it being implanted in your ankle. If a large amount of oxygen diffuses into the plastic insert while it’s being stored and before it is implanted, this can lead to a process called oxidation, which can cause the plastic to wear out earlier than expected or to become damaged after it is implanted into the patient’s body.”
“Exactech has found that the plastic insert in the out of specification bag can wear out earlier than expected in some patients. Premature wear of the plastic insert of your ankle replacement can lead to the need for additional surgery (also known as revision surgery). In those cases where the plastic has worn out earlier than expected or has been damaged, we will evaluate your ankle replacement and decide whether additional treatment is needed. Determination of whether the plastic is worn is accomplished by examining your ankle in the office and obtaining x-rays. After this evaluation is complete, we will decide if additional treatment, including revision surgery, is necessary.”
Explanation of Exactech Ankle Recall
As shown in the diagram below, a standard ankle replacement has three parts:
- The tibial component (this is the metal piece that attaches to your shin bone, also known as your “tibia”)
- The talar component (this is the metal piece that fits into your foot bone, also known as your “talus”)
- The polyethylene (plastic) insert (this is the plastic that fits between the tibial component and the talar component and acts as the new cushion or cartilage for your replaced ankle joint)
Do I Have an Exactech Ankle Replacement Lawsuit? Contact an Ankle Recall Lawyer.
If you or someone you love has been implanted with an Exactech total ankle replacement, you should contact our lawyers today. You may be entitled to financial compensation by filing an Exactech ankle lawsuit.
We offer a Free Case Evaluation and would be honored to speak with you. Please contact us using the form below or by calling (800) 279-6386.