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Posted On June 3, 2022 Personal Injury,Product Liability and Class Action News

Exactech Recalls More than 147,000 Knee and Ankle Devices Manufactured After 2004

June 3, 2022 – Recently, the medical device manufacturer Exactech recalled 147,732 knee and ankle implants. Patients with an Exactech knee or ankle implant manufactured after 2004 may experience bone loss and the need for corrective revision surgery as a result of the non-conforming packaging that exposed the device to oxygen.

Patients who had an Exactech knee and ankle devices implanted should take steps to protect themselves in the wake of this recent development. The Exactech recall lawyers at Console & Associates, P.C. are currently seeking to interview potential claimants and investigate their legal options at no upfront cost.

What Are Exactech Implants?

Exactech is a medical device manufacturer that specializes in creating devices used during joint-replacement surgery. The company manufactures knee, ankle, hip and shoulder replacements, most of which are implanted in patients whose joints were affected by arthritis. On August 21, 2021, Exactech issued a series of recalls pertaining to several of its knee and ankle joint replacements.

Which Exactech Devices Are Affected By the Recall?

According to the most recent list of recalled devices, Exactech has recalled the following models of its ankle and knee replacements:

  • OPTETRAK® All-polyethylene Tibial Components (TKR)
  • OPTETRAK® All-polyethylene Tibial Components (PKR)
  • OPTETRAK® Tibial Inserts (TKR)
  • OPTETRAK® HI-FLEX® Polyethylene Tibial Inserts (TKR)
  • ARTHROFOCUS® Polyethylene Tibial Inserts (TKR)
  • OPTETRAK® Custom Polyethylene Tibial Inserts (TKR)
  • OPTETRAK® LOGIC® Polyethylene Tibial Inserts (TKR)
  • OPTETRAK® RBK® Polyethylene Tibial Inserts (TKR)
  • TRULIANT® Tibial Inserts (TKR)
  • OPTETRAK® Logic RBK Tibial Components (TKR)
  • Vantage® Fixed-Bearing Polyethylene Liner Component (TAR)
  • Vantage® Mobile-Bearing Polyethylene Liner Component (TAR)

In total, there were more than 147,000 recalled knee and ankle devices recalled by the company.

Why Did Exactech Recall Its Knee and Ankle Implants?

Exactech decided to issue a recall of its joint replacement devices after the company learned that many of the company’s products were not placed in packaging that adequately protected the device from exposure to oxygen. According to an official statement by Exactech, “most of our inserts manufactured since 2004 were packaged in out-of-specification … vacuum bags that are oxygen resistant but do not contain a secondary barrier layer containing ethylene vinyl alcohol (EVOH) that further augments oxygen resistance.”

By failing to ensure that its products were not exposed to oxygen, Exactech allowed its devices to potentially get exposed to oxygen. This can lead to a process called oxidation, which often causes the device to break down much sooner than it otherwise would. Exactech explains that the oxidation process can severely degrade various components of the implant and “can lead to both accelerated wear debris production and bone loss, and/or component fatigue cracking/fracture, all leading to corrective revision surgery.”

The Risks of Exactech Knee Implants and Ankle Replacements

The risks associated with the recalled Exactech devices are severe, especially for those patients who are older and for whom undergoing additional surgery raises unnecessary risks of complications. If you have a recalled Exactech device implanted in your knee or ankle, there is the possibility that the device will start to degrade or break down. If this starts to happen, it can lead to bone loss. In fact, Exactech estimates that patients with recalled devices face a three to seven times greater risk of needing revision surgery.

No-Win, No-Fee Help for Exactech Recall Lawsuits

If you have a recalled Exactech device implanted in your knee or ankle, your health may be at risk. If you need a revision surgery, it will undoubtedly interrupt your life and expose you to the additional dangers of what would otherwise be an unnecessary surgery. Of course, you did not know that the device that doctors implanted in your body was not packaged correctly and that it could worsen your overall health. And It shouldn’t be up to you to bear the brunt of these economic and lifestyle costs.

Through an individual or class action Exactech recall lawsuit, patients and their families may be able to pursue financial compensation for the harm that resulted from these recalled devices. The experienced attorneys at Console & Associates, P.C. are currently seeking to interview potential claimants regarding legal actions stemming from the implantation of recalled Exactech devices. Taking part in a class action investigation or an Exactech lawsuit requires no upfront fees or payment.

At Console & Associates, P.C., our Exactech recall attorneys have decades of experience holding medical device manufacturers and other organizations responsible for causing harm to people, and we welcome any questions you may have. You can learn more about the steps you should take and the legal options available to you during a free, no-obligation consultation.

Just call (866) 778-5500 or fill out our secure online contact form to speak to a knowledgeable legal professional today.