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Practice Areas

Medical Device Class Action Lawsuits, Recalls and Defects


It’s estimated that about 30,000 patients have been fitted with IVC devices from Bard and Cook Medical over the past 30 years. Patients and their families who believe they suffered injuries from the devices are now fighting back.

Ethicon Physiomesh Open Flexible


Ethicon, a division of Johnson & Johnson has announced it is removing a popular hernia repair product, Ethicon Physiomesh, from the market after it was found to cause severe side effects and surgical revisions.



Renewed attention has been focused on bioprosthetic valves manufactured by Milan based Sorin. Previous studies indicated that the Sorin Mitroflow pericardial valve, which is used to replace damaged or diseased heart valves, had a higher than normal rate of failure.


essure lawsuitEssure Permanent Birth Control Safety Concerns

The Essure contraceptive device has injured thousands of women since it was approved by the FDA in 2001. Over 15,000 adverse events have been reported through the FDA reporting process. FDA reported injuries include perforations of the fallopian tubes, pain, heavy bleeding, fatigue, hair loss and even death.


stryker-rejuvenate-abg-ii-lawsuitStryker Rejuvenate & Stryker ABG II Hip Implant Neck Stem Device

Stryker Orthopaedics has recalled two devices that are used with hip implant devices in paitents undergoing hip replacement surgery. This recall comes on the heels of multiple reports of problems or adverse events related to complications or defects with both the Stryker Rejuvenate Modular Neck Stem as well as the Stryker ABG II Modular Neck Stem. Patients have reported tissue swelling and pain related to both hip implant components.


Sorin 3T Heater Cooler SystemSorin Stockert 3T Heater Cooler

While the Sorin Stockert 3T is the most popular brand, medical device design experts have found significant flaws in the device including defects in the direction of airflow exhaust, a water circuit that is not airtight, original PVC tubing that promotes biofilm, an inability to access water tank & internal circuits leading to the production of biofilm, and problems with the force at which air is vented.


Knee Replacement ImplantDePuy Knee Replacement Recall

The implant is one of company’s most recent ventures, which it markets as having “patented technologies” that improve range of motion and give patients “the confidence of a stable knee replacement.”


Zimmer Persona Trabecular Knee ImplantZimmer ® M/L Taper with Kinectiv® Technology Recall

Although only on the market for less than one month, from March 31, 2015 through April 20, 2015, the FDA announced that a Class 1 Recall is in effect as of June 8, 2015, for Zimmer’s M/L Taper with Kinectiv® Technology. A Class 1 recall is the most urgent classified by the FDA.


Zimmer Persona Trabecular Knee ImplantZimmer Persona Trabecular Knee Implant Recall

The Trabecular Metal Tibial Baseplate of the Zimmer Persona Knee was Recalled on January 21, 2015. These knee implants had a high failure rate as a result of loosening of the tibial plate in the implant.


granuflo-heart-attackGranuFlo Dialysis Medicine Causes Heart Attacks and Strokes

GranuFlo is a dry acid component of the blood cleansing mixture that is used by many commercial hemodialysis clinics. Dialysis is a process for cleaning the blood and eliminating the waste from the blood of people who have renal failure. Renal failure is the failure of the kidneys to clean the blood to eliminate waste from the blood.


depuy-hipJohnson & Johnson DePuy Orthopaedic Hip

The Johnson & Johnson Depuy artificial hip implant has been recalled due to adverse event reports that between 12% and 13% of the Johnson And Johnson DePuy hip implants had to be surgically removed and replaced with new implants.


biomet-hip-replacement-lawsuitBiomet Hip Replacement Lawsuit

Saunders & Walker P.A. has filed a federal lawsuit against Biomet Orthopedics, LLC and Biomet Inc. regarding defective metal on metal Biomet M2-a Magnum hip replacement systems. There have been numerous adverse event reports associated with this hip system.


smith and nephewSmith And Nephew Hip Replacement Implant Recall

The Smith & Nephew R3 hip implant that was recalled in 2012 is an implant that has a metal liner in the acetabular cup that interfaces with a metal ball. This hip implant is similar in design to the Zimmer Durom Cup and the DePuy ASR that were also recalled in that they all have a metal on metal articulation. The R3 is even more similar to the DePuy Pinnacle Ultamet which is also a metal liner in the acetabular cup.


wright pro femur lawsuitWright Medical Profemur Hip Implant

The FDA has expanded its recall of the hernia mesh patch designed by Dr. Robert D. Kugel and manufactured by Davol, Inc. (a subsidiary of C.R. Bard). The FDA sent a letter to health care professionals and distributors on January 10, 2007 notifying them of the most recent expansion of the recall.


vaginal-mesh-attorneyTransvaginal Mesh

A new FDA study indicates that the Johnson & Johnson mesh or transvaginal mesh as well as those made by Bard and used in female surgeries for pelvic organ prolapse (POP) and stress urinary incontinence (SUI) may cause permanent injury to women rather than benefiting them.


hernia-meshKugel Hernia Mesh Recall

The FDA has expanded its recall of the hernia mesh patch designed by Dr. Robert D. Kugel and manufactured by Davol, Inc. (a subsidiary of C.R. Bard). The FDA sent a letter to health care professionals and distributors on January 10, 2007 notifying them of the most recent expansion of the recall.


stryker-4smZimmer Durom Hip Implant Recall

The implantable hip device is manufactured by Zimmer Holdings. The Zimmer hip, has received complaints from surgeons and patients who state that the design is flawed causing many patients to undergo revision hip surgery.


stryker-5 Stryker Trident Hip Implant Recall

Stryker Corporation has issued a temporary recall of its Trident PSL and Trident Hemispherical Acetabular Cups used in hip replacement surgery. The recall was issued one week after teh US FDA issued a warning letter about defects in the manufacturing processes at its Mahwah, New Jersey plant.


guidant-defibrillator-recallMedtronic Sprint Fidelis Defibrillator Lead Failure

Medtronic reported that, as of October 4, 2007, there were approximately 268,000 Sprint Fidelis leads implanted worldwide, including 172,000 in the United States. Of the 268,000, about 235,000 patients still have the leads. Medtronic revealed that lead fractures may have been a possible or likely contributing factor in five patient deaths.


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Saunders & Walker
3491 Gandy Blvd
Pinellas Park, FL 33781
Phone: (727) 579-4500
Phone: 1-800-748-7115

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