Tag: exactech lawsuits

Optetrak Patella Implant Device Exactech Recall

Posted on by Loni Liss

A letter was recently sent to surgeons, hospitals, and healthcare professionals announcing the voluntary recall of the Exactech Optetrak Patella implant device.

The voluntary Exactech recall concerns Patella lots that were packaged without the ethylene vinyl alcohol (EVOH) layer. Experts advised doctors not to implant these potentially harmful devices packaged in faulty packaging.

Medical professionals were advised to stop using the product immediately and set aside any that might be affected. They were instructed that healthcare professionals should report any adverse reactions or noticeable quality issues as patients come forward.

Our attorneys handle Exactech recall lawsuits nationwide. If you’ve experienced failure of an Exactech knee, hip, or ankle implant that was recalled, leading to revision surgery, we’re here to help.

Stay informed with the latest updates and insights on this page.

Don’t overlook your rights—contact our product liability lawyers at 800-967-8529 or online. You won’t incur any fees unless you receive financial compensation.

Exactech Optetrak Patella recalled medical device

Exachtech Addresses Oxidation Risk with Packaging Recall

From 2004 to August 2021, Exachtech used two types of packaging materials in its process: (1) Low-Density Polyethylene (LDPE), Nylon, and EVOH, or (2) LDPE and Nylon without EVOH.

EVOH improves the prevention of oxygen permeation. Thousands of devices were packaged without using an EVOH oxygen barrier layer, which potentially causes unintended oxidation and early degradation of the affected device.

Given the potential for oxidation-related issues, Exachtech voluntarily recalled these lots as a precautionary measure.

The recall emphasizes the importance of surgeons regularly monitoring patients with affected devices for signs of wear and failure. The crucial issue is determining how many thousands of patients might suffer from device-related pain or failure, potentially needing revision surgery.

knee replacement recall lawsuit by The Yost Legal Group

Stay Informed on Patella Device Recall and Risks

The lot-specific voluntary recall relates to Patella devices manufactured from 2004 through August 2021. These devices were marketed as Optetrak and cleared through 510(k): K932690, K933610, and K160484.

All healthcare professionals were instructed to review the following information and take any necessary actions. Then, the information advised diagnostic considerations, such as performing X-rays to evaluate the patient further if device failure is suspected.

Potential issues due to oxidation include:

–             Accelerated device wear or failure

–             Component cracking or fracture

–             New or worsening pain

–             Bone loss

–             Swelling in the affected area

Key Information on Optetrak Device Failures

The recall names all of these knee replacement devices, which could necessitate revision surgery for patients.

Part Number Device Description                                                         Device Identifier

200-02-26        THREE PEG PATELLA 26MM                                    10885862039576

200-02-29        THREE PEG PATELLA 29MM                                    10885862039583

200-02-32        THREE PEG PATELLA 32MM                                    10885862039590

200-02-35        THREE PEG PATELLA 35MM                                    10885862039606

200-02-38        THREE PEG PATELLA 38MM                                    10885862039613

200-02-41        THREE PEG PATELLA 41MM                                      10885862039620

200-03-26        ONE PEG PATELLA 26MM                                         10885862039637

200-03-29        ONE PEG PATELLA 29MM                                         10885862039644

200-03-32        ONE PEG PATELLA 32MM                                         10885862039651

200-03-35        ONE PEG PATELLA 35MM                                         10885862039668

200-03-38        ONE PEG PATELLA 38MM                                         10885862039675

200-03-41        ONE PEG PATELLA 41MM                                          10885862039682

200-05-23        INSET PATELLA 23MM                                              10885862039835

200-05-26        INSET PATELLA 26MM                                               10885862039842

200-05-29        INSET PATELLA 29MM                                               10885862039859

200-07-26        ADVANCED PATELLA 26MM 3 PEG IMPLANT  10885862314260

200-07-29        ADVANCED PATELLA 29M 3 PEG IMPLANT      10885862314277

200-07-32        ADVANCED PATELLA 32MM 3 PEG IMPLANT  10885862314284

200-07-35        ADVANCED PATELLA 35MM 3 PEG IMPLANT  10885862314291

200-07-38        ADVANCED PATELLA 38MM 3 PEG IMPLANT  10885862314307

Exactech lawsuits by The Yost Legal Group

The Hidden Dangers of 510(k) Fast-Track FDA Approvals

Between 1994 and 2017, Exactech secured multiple 501(k) clearances from the FDA for its Optetrak, Optetrak Logic, and Truliant total knee replacement implant systems and components.

The FDA’s 510(k) clearance, known as “fast-track” approval, does not require manufacturers to prove a product’s safety and effectiveness.

This process, known as “premarket notification” or 510(k) clearance, only requires the manufacturer to demonstrate that the device is substantially equivalent to a pre-MDA predicate device.

Consequentially, the FDA can “clear” a new device for sale in the USA. Under the 510(k) process, the component parts used in the Exactech Optetrak Devices were either approved by the FDA or marketed without receiving either 510(k) clearance or full approval by the FDA.

Simply put, not enough product development and testing was done to ensure product safety. This can lead to patient harm and potential recalls, which is precisely what has happened.

Protect Your Rights Against Defective Medical Products

At Yost Legal Group, our priority is ensuring patient safety and achieving effective outcomes for patients with life-altering defective medical products. Our knee replacement lawsuit attorneys will help you file a lawsuit to seek compensation.

Collaborative efforts are essential for the success of actions against medical device manufacturers—especially those who continuously market harmful products.

Our law firm is dedicated to defending the rights of individuals against powerful corporations. Accordingly, when huge medical device manufacturers like Exactech continue to put profits before people, we step in to level the playing field.

Learn about your legal rights. We can file a product liability case on your behalf if you have a defective medical device. The Yost Legal Group is filing the current personal injury lawsuits:

  • Knee replacement recall
  • Shoulder replacement recall
  • Hip replacement recall
  • Exactech lawsuits

Empowering Patients, Challenging Corporations

If you or a loved one had knee replacement surgery in the past ten years and are experiencing pain, a clicking noise, swelling, or any other medical concerns, contact your doctor immediately.

Contact The Yost Legal Group for a free and confidential consultation at 1-800-967-8529. Our personal injury law firm is committed to promptly and transparently addressing potential concerns. If you had knee replacement surgery and are affected by the Exactech knee recall, please contact us.

Hold Exactech accountable for the harm they’ve caused. Our legal team is committed to seeking justice and ensuring they change their ways. A product defect lawyer will file an Exacteck lawsuit on your behalf.

For more information or to discuss your case, call us at 1-800-967-8529 or click this link to request an appointment.

By pursuing an Exactech knee replacement lawsuit, you will help send a powerful message for change. You may qualify for a significant financial recovery.

At The Yost Legal Group, you never have to pay anything upfront. We only get paid after we settle your case. If there is no recovery, no legal fees or expenses are due. Our personal injury law attorneys will provide legal representation with a free case evaluation.

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Consumers are encouraged to report any adverse events or quality concerns related to this recall to the FDA through the MedWatch reporting system. You can go online at the FDA Medwatch Website or call 1-800-FDA-0178.

Exactech Hip Replacement Lawsuit Update 2023

Posted on by Loni Liss

Protect your rights by filing an Exactech Hip Replacement Lawsuit. Exactech is a global medical device company that creates orthopedic implant devices and surgical instrumentation for joint replacement surgeries. As a result of premature device failure, thousands of people require revision surgery or have developed serious health issues, such as Osteolysis.

If you or a loved one had any of the following surgeries, and the Exactech implant was used, you may qualify to file a claim against Exachtech.

– knee replacement surgery

– hip replacement surgery

– ankle replacement surgery

Did you have revision surgery for your hip replacement, knee replacement, or ankle replacement?

Did you receive a letter saying you require revision surgery?

Have you been diagnosed with Osteolysis after having hip, knee, or ankle replacement surgery?

Did you have hip replacement complications from the Exactech hip recall?

knee revision surgery after a defective exactech medical device

Protect yourself with the help of experienced Exactech lawyers

If you answered yes to any of the above, contact The Yost Legal Group at 800-967-8529 for a free, confidential consultation. We will answer your questions and inform you about the current Exachtech litigation. You may qualify to file a Hip Replacement Lawsuit.

Lawsuits have been filed against Exactech by victims seeking compensation for:

– past medical expenses

– future medical expenses

– pain and suffering

hip revision surgery after a defective exctech recall lawsuit

Exactech Hip Replacement Lawsuit Timeline

May 2023

Judge Donna Keim of Gainesville, FL, organized a special “science day” focused on Exactech implants. Two esteemed judges, Judge Nicholas Garaufis and Judge Marcia M. Henry from the Eastern District of New York, were invited to participate.

During this unique gathering, experts representing the plaintiff and defense sides of the Exactech lawsuit shared valuable insights on various aspects of the case.

Topics included the science behind hip and knee replacements, revisions, the materials used in the recalled Exactech implants, and the packaging materials. Additionally, other issues related to the recalled devices were also addressed.

Science Day was a significant opportunity for the judge to deepen her understanding of the recalled devices and raise pertinent questions. Moving forward, regular case management conferences will be held by the judges as the discovery phase progresses in the Exactech lawsuits. This ensures a thorough and practical examination of the matter at hand.

March 2023

The FDA warns patients and healthcare providers who have used Exactech joint replacement devices between 2004 and August 2021. They communicated about the recall of specific devices manufactured during this period.

The recalled Exactech joint replacement devices, including knees, ankles, and hips, were found to have been packaged in defective packaging bags. These bags lacked an essential oxygen barrier layer, which serves to protect the devices from oxidation – a chemical reaction that can deteriorate plastics over time.

The consequences of oxidation can be severe, resulting in accelerated device wear/failure, as well as component cracking or fracture. These issues may ultimately necessitate corrective revision surgery. It is important to note that some of the recalled devices are also associated with an increased risk of revision surgeries and bone loss due to excessive device wear/failure.

The FDA urged patients and healthcare providers to be aware of this recall and take the necessary steps to address potential risks or concerns. It was advised to contact the appropriate healthcare professionals to discuss further actions, such as device replacement or additional monitoring.

January 2023

Exactech pushes for official coordination and consolidation of federal and state court litigations related to the Exactech implant recalls.

December 2022

A rapid increase in lawsuits related to the Exactech recall has been filed into the Exactech MDL 3044.

October 2022

Due to the volume of cases filed, lawsuits involving the recalled knee and ankle products were consolidated into a Multi-District Litigation (MDL) in the Eastern District of New York. Similarly, many recalled hip and ankle products filed in Florida remain consolidated in the Florida state courts. Over a year later, over 850 lawsuits are pending in the MDL, and over 200 are pending in the Florida courts.

February 2022

To avoid paying patients what they truly deserve, Exactech chose early on to provide a settlement option upfront for its victims. Exactech retained the services of Broadspire, a third-party settlement administrator and risk management firm, to handle the claims reimbursement process.

Patients were encouraged to file a claim with Broadspire and obtain reimbursement for their out-of-pocket medical expenses only.

Essentially, Broadspire was hired by Exactech to lure victims in by appealing to people’s desire for quick money without the need for a lawyer. However, it is essential to remember that Broadspire is a risk management company whose sole purpose was to minimize the financial damage to Exactech.

The Broadspire settlement option only reimburses patients for medical expenses paid that insurance did not cover. This significantly reduces the amount of financial compensation Exactech will have to pay out.

Lost wages, related medical bills, and non-economic damages, such as pain and suffering, are not part of the calculus. A settlement through Broadspire will NOT compensate you for all of your damages.

Submitting a claim through Broadspire will impact your legal options against Exactech.

June 2021

Exactech issued recalls of its knee, hip, and ankle implant systems. They said defective packaging caused the polyethylene inserts to oxidize and deteriorate rapidly. This ultimately led to a premature failure of the devices.

At The Yost Legal Group, patients’ well-being is our top priority. We are here to provide support and guidance throughout this process. Please stay informed and take the necessary precautions to ensure your safety. 

Get the compensation you deserve for a Defective Exactech Medical Device

If you or a loved one has an Exactech hip or knee implant and still need to file a claim against Exachtech, call one of our experienced Exactech lawyers for help. A product liability lawyer at The Yost Legal Group will fight to recover your maximum settlement.

Even if you have already received a settlement through Broadspire, we strongly advise you to speak with one of our knee replacement recall attorneys today.

Call The Yost Legal Group at 1-800-YOST-LAW (1-800-967-8529) or email us at info@yostlaw.com today for a free consultation. There is no fee or expense unless you recover.

If you had an Exactech knee replacement failure or revision hip replacement, we would file an injury claim for you. Our injury lawyers will review your medical records and analyze the premature wear of your medical device.

We will talk with you about your loss of “quality of life” because of your failed medical device and how it has impacted your life.

The Yost Legal Group has years of experience handling defective product cases. We will file an Exactech lawsuit and ensure your rights are fully protected. If you have a failed knee replacement or failed hip replacement, call us.

We will support your fight for justice and hold Exactech rightfully accountable for their defective products.

The Yost Legal Group personal injury lawyers are filing exactech recall lawsuits for patients injured from the defective exactech hip replacements

Why contact The Yost Legal Group personal injury lawyers

Our personal injury law attorneys have years of experience representing medical malpractice, product liability, and defective medical device claims. We are filing Exactech lawsuits against the manufacturer. The Exactech recall has affected thousands of patients.

An Exactech recall lawsuit will protect your rights to receive financial compensation to cover your pain and damages.

Our Exactech attorneys are here to explain the hip implant failure lawsuit and knee implant failure lawsuit. If you have had a hip revision surgery or knee revision surgery due to a defective Exactech implant, we are here to help.

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Contact us at the Yost Legal Group for a free initial consultation. We can help to provide information about ongoing litigation or discuss the circumstances of your individual case. There is no fee or expense unless you recover.