FDA Reminds Patients and Physicians About the Exactech Recall Letter
On March 23, 2023, the U.S. Food and Drug Administration (FDA) wanted to remind patients and healthcare providers that Exactech recalled their hip, knee, and ankle implants that Exactech manufactured between 2004 and August 2021, and recalled in 2021 and 2022. The FDA noted that “Many Exactech joint replacement devices (including knees, ankles, and hips) were packaged in defective packaging bags. The defective bags were missing one of the oxygen barrier layers that protect devices from oxidation, a chemical reaction with oxygen that can degrade plastics over time. Oxidation can lead to accelerated device wear/failure, and component cracking or fracture, all leading to corrective revision surgery. Some of the recalled devices are associated with increased risk of revision surgeries and bone loss related to excessive device wear/failure.”
FDA Recommendations For Health Care Providers Receiving an Exactech Recall Letter
The FDA recommended the following to any health care provider that receives an Exactech hip, knee, or ankle recall letter:
- Do not implant any hip, knee, or ankle recalled by Exactech
- Based on currently available information, the FDA does not recommend removal of a well-functioning recalled Exactech joint replacement devices from patients who do not have any new or worsening pain or symptoms
- Monitor patients who have any implanted devices manufactured by Exactech between 2004 and August 2021, because all of those hip, knee, and ankle implants were recalled by Exactech. Monitor the recalled Exactech devices for potential device wear, failure, or bone loss. Consider performing X-rays to further evaluate a patient and their implanted recalled Exactech device if you suspect a failed Exactech implant.
- Discuss revision surgery with patients who were implanted with a recalled Exactech hip, knee, or ankle if they are having worsening pain or joint weakness that is potentially attributable to the Exactech device based on clinical exam, on a case-by-case basis. As part of the shared decision making process, the FDA recommends discussing the benefits and risk of all relevant treatment options related to the Exactech recall.
- Remove all recalled Exactech hips, knees, and ankles and return them to Exactech.
FDA Recommendations For Patients Receiving An Exactech Recall Letter
The FDA recommended the following to any patient that receives an Exactech hip, knee, or ankle recall letter:
- If your knee, ankle, or hip replacement device is functioning well and you have no pain or symptoms, the FDA does not recommend surgery to remove well-functioning Exactech joint replacement devices, even though recall letters were sent out on the Exactech implant.
- Contact your health care provider if you have any Exactech joint replacement device implanted and you have any new or worsening pain or swelling, inability to bear weight, grinding or other noise, or weakness around your implanted Exactech device.
- If you have your Exactech device serial number, you can search Exactech’s online database to see if your hip, knee, or ankle was part of Exactech’s recall.
Contact Our Exactech Attorney If You Received An Exactech Recall Letter
Statute of limitations can limit the time to file an Exactech lawsuit in relation to any Exactech recall letter that you may have received. Contact our Exactech attorneys today for a free Exactech lawsuit case evaluation. Call 202-792-7927 if you received an Exactech recall letter for a free case consultation. Enable our Exactech attorneys the ability to best represent you by contacting them today.