200,000 Large Joint Implants Recalled

The numbers are in for a recall involving packaging for defective knee, ankle, and hip replacements manufactured by Exactech, Inc. At least 200,000 of these devices have been recalled.

The recall involves packaging for joint replacement devices manufactured by Exactech between 2004 and 2021. The devices were recalled in 2021 and 2022.

The recalls occurred because of defective packaging bags. According to the U.S. Food and Drug Administration (FDA) safety communication, 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.” The FDA explained in the safety communication, oxidation can lead to the risk of the following:

• early and excessive device wear,
• component fracture,
• device failure,
• new or worsening pain,
• more bone loss,
• swelling in the affected area, or
• revision surgery as a result of these issues.

According to the FDA, the knee and ankle replacement devices that Exactech voluntarily recalled include the following: Optetrak, Logic, and Truliant knee replacements and Vantage total ankle replacements. The FDA also provided that the hip replacement devices that Exactech voluntarily recalled include the following: certain GXL Liners for Novation, Acumatch, and MCS hip replacement devices and all hip devices with polyethylene components packaged in defective bags.

The recall numbers are not the only numbers the medical device company may have to worry about. The company has been facing lawsuits filed by patients who received the implants. The litigation against Exactech is progressing as multidistrict litigation. For OTW’s previous coverage of the Exactech litigation and recalls, see “Exactech Ortho Implant Lawsuits Granted Multidistrict Litigation.”

The Lanier Law Firm is one of the law firms involved in the litigation. Evan M. Janush is the managing attorney of the New York office of The Lanier Law Firm. In a transcript on the law firm’s website discussing the lawsuit, Janush stated in part, “This company [Exactech] may have known for as long as 17 years that they failed to appropriately package their product in a way that would preserve the polyethylene plastic implant component so that it would not be subject to oxygenation or oxygen.”

Janush further asserted, “This is not a case addressing that the design of the actual implant was flawed, negligent, or irresponsible. Instead, this is really a case addressing how the packaging and the shipment, the storage of this product, was irresponsible, negligent, and led to injury.”