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 recall was issued on Feb. 7, 2022. The Exactech ankle recall is centered around one component and insert of the ankle replacement device.
On Mar. 23, 2023, the FDA issued a reannouncement of recalled Exactech medical device products. The majority of the recalled joint replacement devices (knees, ankles and hips) were defectively packaged. The bags were missing an oxygen barrier intended to protect against oxidation.
Why is the Exactech Ankle Replacement Being Recalled?
According to 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.”
What symptoms can a patient experience with a recalled ankle replacement product?
Patients with an implanted Exactech ankle replacement can experience:
- New or worsening pain while walking
- Lack of stability
- Pain while bearing weight
- Swelling in or around the impacted joint
- Clicking or grinding noises and/or sensations from the joint
- Joint dislocation
- Pain in joint of affected ankle
What models are affected by the recall?
Recalled Exactech knee and ankle replacements include the following models:
- Optetrak All-Polyethylene CR Tibial Components
- Optetrak All-Polyethylene PS Tibial Components
- Optetrak CR Tibial Inserts
- Optetrak CR Slope Tibial Inserts
- Optetrak PS Tibial Inserts
- Optetrak Hi-Flex PS Tibial Inserts
- Optetrak Logic CR Tibial Inserts
- Optetrak Logic CR Slope Tibial Inserts
- Optetrak Logic CRC Tibial Inserts
- Optetrak Logic PS Tibial Inserts
- Optetrak Logic PSC Tibial Inserts
- Optetrak Logic CC Tibial Inserts
- Truliant CR Tibial Inserts
- Truliant CR Slope Tibial Inserts
- Truliant CRC Tibial Inserts
- Truliant PS Tibial Inserts
- Truliant PSC Tibial Inserts
- Vantage Fixed-Bearing Liner Component
Consumers can also check their product’s serial number on Exactech’s recall serial number checker website.
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)
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Questions About an Exactech Ankle Replacement Lawsuit? Contact a Johnson//Becker Lawyer for a Free Case Review.
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.
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