What is Exactech?
Exactech is a large medical-device company located in Gainesville, Florida. Exactech has offices and distributors in the United Kingdom, Spain, Switzerland, Korea, France, Japan, Australia, Italy, and the United States.
What is the main problem related to Exactech?
Exactech issued an Urgent Medical Device Correction Notice informing surgeons that most of the Exactech knee, ankle, and hip inserts that were manufactured from 2004 until 2022 contained nonconforming packaging layers, which can lead to oxidation.
How many people have been involved in this problem?
Exactech estimates that approximately 147,732 inserts implanted in the United States since 2004 had been produced with nonconforming packaging. The U. S. Food and Drug Administration classified the recall as a Class II recall, which occurs when consumers might experience severe health consequences of a temporary or medically reversible nature.
•Which Exactech devices are involved in the recall?
Recalled knee and ankle devices include the following:
•Optetrak: 60,926 implanted units since 2004
•Optetrak Logic: 60,518 implanted units since 2004
•Truliant knee replacement: 24,727 implanted units since 2004
•Vantage ankle implants: 1,561 implanted since 2004
Connexion GXL hip replacement recall
In addition to the recalls for knee and ankle implants, Exactech recalled approximately 90,000 hip replacements with Exactech Connexion GXL Liners in June 2021. The company sent an Urgent Healthcare Professional Communication to surgeons, hospitals, and healthcare professions regarding this recall.
What should patients with recalled Exactech implants do?
If your surgeon has not yet contacted you, Exactech has also published an online list of affected devices, product codes, descriptions, and serial numbers to determine whether your device has been recalled. https://www.exac.com/medical-professionals/recall-information/
You will need to enter the serial number of your device, which can be found in your medical records.