FDA Safety Communication – Risks with Recalled Exactech Devices

FDA Safety Communication Exactech Recalled Devices

An FDA Safety Communication has been issued regarding the recall of Exactech hip, knee, and ankle implants. The recall, which began in the summer of 2021 with hip replacement devices, expanded to include many knee and ankle implants as well.

Exactech’s recalled devices have polyethylene inserts that wear too early, cause pain and can lead to the need for revision surgery.

FDA Safety Communication

“March 23, 2023. The FDA issued a safety communication to remind patients and health care providers about the joint replacement devices manufactured by Exactech between 2004 and August 2021 and their recalls in 2021 and 2022.”

Read the complete Safety Communication.

The problem: The recalled Exactech joint replacement devices contain a plastic component which should be in packaging that contains multiple oxygen barrier layers (as indicated in the package specifications). The recalled devices were packaged in defective bags that were missing one of these layers; layers that help protect the components from oxidation.

Exactech recalled the devices because around 80% of the knee and ankle replacement devices manufactured since 2004 were packaged in defective bags.

knee replacement complications recall of Exactech hip Exactech hip knee and ankle implantsOxidation can occur when oxygen from the air contacts the plastic component before getting implanted. Oxidation, a chemical reaction with oxygen that can degrade plastics over time, can lead to accelerated device wear/failure and component cracking or fracture. The end result is often a corrective revision surgery.

Patients run the risk of:

  • 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

Questions? Call us at (877) 284-6600.

The Safety Communication provides patients and health care providers:

  • Recommendations
  • Background information on the issue
  • FDA’s actions to address the issue
  • Instructions to report problems

Status of Lawsuits

The Nash & Franciskato Law Firm, along with co-counsel, are speaking with and representing those who received the recalled Exactech implants and suffered injuries associated with excessive wear leading to early device failure.

Exactech recall lawsuits are moving forward in both Florida state courts and federal courts. The first cases were filed in the Florida state court in Gainesville, FL and the first trial for these state cases has been set for November 6, 2023.

Patients from anywhere in the United States can file a claim in Florida because Exactech’s corporate headquarters are located there.

Franciskato Member of Plaintiff Steering Committee

Brian Franciskato Super Lawyer Plaintiff Steering Committee FDA Safety Communication

Brian Franciskato, trial lawyer and partner, is a member of the Plaintiff Steering Committee for the consolidated Exactech lawsuits in Florida’s Eighth Judicial Circuit for recalled hip, knee and ankle implants.

A Plaintiff Steering Committee (PSC) includes attorney members of the State Court consolidated proceeding in Florida who are appointed to lead the common interests of all plaintiffs.


If you have been hurt by one of Exactech’s recalled devices, contact the law firm of Nash & Franciskato to find out if you have a case against Exactech at (877) 284-6600. We will review your case in a confidential consultation and will provide you with a free, no-obligation review of your case.



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