Product liability attorney investigates defective Stryker shoulder implants for injured plaintiffs nationwide
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Stryker Shoulder Recall Lawyer

Medical Device Defect Attorney Reviewing Stryker Implant Cases

In December, 2016, Stryker Corporation officials sent a warning notice to orthopedic surgeons using the ReUnion TSA shoulder replacement system. According to the warning, Stryker acknowledged the device may fail during surgery. Stryker shoulder replacement system failures may compromise the implant’s effectiveness and the patient’s health.

Stryker stated the reason for recall was that the Reunion TSA Peg Alignment Sound may break during surgery. The Peg Alignment Sound is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA prior to final implantation.

In response, the U.S. Food and Drug Administration (FDA) issued a January, 2017 recall notice for the Reunion TSA Peg Alignment Sound device. The device is manufactured by Howmedica Osteonics Corp., a subsidiary of Stryker Corporation.

This is a Class 2 recall, which the FDA issues when a product may cause “temporary or medically reversible adverse health consequences.” A Class 2 recall is the second-most serious recall classification measured by the FDA.

Anybody with a Stryker ReUnion Total Shoulder Arthroplasty (TSA) System should contact their doctor if there are symptoms of failure. Defective implant issues may require extensive and painful revision surgery.

Joe Lyon is a highly-rated product liability lawyer and medical device lawyer representing plaintiffs nationwide in a wide variety of civil litigation claims.  

Stryker’s ReUnion TSA Device

This is not the first recall for the ReUnion replacement device. In 2007, Stryker recalled its shoulder prosthesis, the ReUnion Fracture Stem Humeral Component, because the plasma spray component was known to delaminate from the proximal portion of the humeral stem. Again in 2015, Stryker recalled the ReUnion model.

Stryker’s ReUnion Total Shoulder Arthroplasty (TSA) System was designed to address common arthritic disorders affecting the shoulder as well as various fractures of the proximal humerus.

In most cases involving both the humeral head and the glenoid, a total shoulder arthroplasty may be performed. However, occasional complications and post-operative issues may harm a patient’s quality of life, in contrast to the original intention to improve issues with movement and discomfort.

Complications of Stryker Shoulder Implants

The U.S. Food and Drug Administration (FDA) has warned in the past that certain patients with defective implants may experience the following side effects:

•    Severe pain
•    Inflammation
•    Implant failure
•    Adverse tissue reactions
•    Joint instability
•    Infection
•    Nerve damage

Stryker Shoulder Implant Recalls

Stryker is one of the largest orthopedic and device companies in the world. Stryker Corp. has around $9 billion in annual revenue. Its hip, knee, shoulder and bone products are used by millions worldwide. Unfortunately, thousands of patients have received recalled Stryker products. Some of Stryker’s recalls for medical devices include:

•    In recent years, the FDA warned Stryker that components of their Scorpio and Duracon knee implants were not conforming to manufacturing standards.
•    In July, 2012, Stryker Orthopaedics recalled the Rejuvenate and the ABG II modular-neck hip stems.
•    In 2013, Stryker recalled the Accolade modular system. In 2014, the company settled thousands of lawsuits for over $1 billion.

Stryker Forearm Implant Devices Recalled

Five additional medical devices manufactured by Stryker Howmedica Osteonics—the same company which produced the TSA system implants—were recalled in June, 2016. The five Stryker implant devices recalled include the following:

•    Recon radial implant
•    rHead lateral stem
•    Sigmoid Notch radial plate
•    uHead ulnar implant
•    Radio-Capitellum

According to the U.S. Food and Drug Administration Stryker recalled nearly 17,000 arm implant devices in August, 2015 because their packaging could have been compromised during transportation

Failing Stryker Shoulder Implant Devices

Patients who have received a Stryker Total Shoulder Arthroplasty system should consult with their implanting surgeon, especially if they experience uncommon pain, or other post-operative complications.

The FDA approval process for new medical devices has long been too lenient. As a result, many of Stryker’s products like TSA shoulder systems allegedly injure American consumers. Injured patients and experienced attorneys are forcing large medical device companies like Stryker to claim responsibility for the damaging products they continue to market and distribute.


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Joseph Lyon has 17 years of experience representing individuals in complex litigation matters. He has represented individuals in every state against many of the largest companies in the world.

The Firm focuses on single-event civil cases and class actions involving corporate neglect & fraud, toxic exposure, product defects & recalls, medical malpractice, and invasion of privacy.


The Firm offers contingency fees, advancing all costs of the litigation, and accepting the full financial risk, allowing our clients full access to the legal system while reducing the financial stress while they focus on their healthcare and financial needs.

photo of attorney Joe Lyon reviewing stryker shoulder implant cases
A Voice for Those who have suffered

Why are these cases important?

Defective medical device litigation helps to improve patient safety and holds medical device companies accountable when defective products injure plaintiffs and clients.


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Questions about Medical Device Litigation

Can I file a Defective Medical Device Lawsuit?

When a shoulder implant has the potential to fail and cause injury, companies should voluntarily issue a recall. When a company injures patients with defective shoulder implants, a medical device lawyer may help you recover financial losses, medical expenses and other damages incurred through litigation.

How is a Shoulder Implant Defined as Defective?
Ohio Definition of Defective

A product is defective if it is unreasonably dangerous for its intended use. A legal cause of action can be based on several types of product defects. The following are Cincinnati product liability and strict liability claims available in Ohio and in most jurisdictions nationwide:

(1)  Manufacturing/ Construction Defect:

These issues arise where the product is released from the factory in a manner that deviates from the intended design or specifications. The defect can be a result of using the wrong materials, including the wrong or completely foreign materials.

As a result of the deviation, the product enters the market in an unreasonably dangerous condition and the consumer is exposed to or purchases a product that is defective. Any personal injuries or economic loss that arise from the the defect are compensable under Ohio product liability law.

(2) Defective design and/or formulation:

Defective design product liability cases arise not because a mistake was made during the manufacturing process, but rather the original design of the product is unreasonably dangerous. A “risk benefit analysis” is used to determine whether safer/less expensive alternative designs were available to the manufacturer.

Federal regulations set minimum standards for the design of many consumer products, and preemption defenses may preclude liability in some situations if the manufacturer follows and obtains federal approval for a product. 

(3) Failure to warn or inadequate warning or instruction associated with the product:

All consumer products come with necessary and appropriate warnings and instructions for use. If the lack of a warning makes the product and use of the product unsafe, the manufacturer is liable for the failure to place the warning. 

Medical Device manufacturers are required to warn of the known or foreseeable side effects and update the warnings in a timely manner. Litigation arises where there is evidence the manufacturer failed to timely update a warning in light of new data or simply ignored the risk and failed to conduct sufficient research to identify and then disclose the risk.

(4) Misrepresentation:

The product fails to conform to a representation or warranty. Warranty claims are more common in commercial and economic loss cases than in personal injury cases. In many States, The Product Liability Act does not apply to cases with only economic loss, because the Commercial Code provides recourse for breach of warranty.

The warranty may be written or implied based upon the products intended purpose and merchantability. 

How do you prove implant design defects?

Risks:  The following factors are considered under Ohio law when determining the risks associated with the design of a product:  (1) the magnitude of the risk of injury; (2) ordinary consumer awareness of the risk for injury; (3) the likelihood of causing injury; (4) the violation of a private or public standard; and (5) the consumer’s expectation of the performance of the product and level of danger. Ohio Revised Code 2307.5 (B) Product Defective in Design or Formulation.

BenefitsThe following factors are considered under Ohio law when determining the benefits associated with product design: (1) the utility of the product; (2) availability of an alternative design; (3) the magnitude of risks associated with an alternative design. Ohio Revised Code 2307.5 (c)

Defenses for Defective Design(1) a pharmaceutical drug or medical device is not defective by design if it contains an adequate warning of an unavoidably unsafe aspect of the medical device; (2) the dangerous aspect is inherent to the product, recognizable, and cannot be eliminated without compromising the product’s usefulness; (3) a lack of a feasible alternative design. 2307.75 (d)(e)(f).

What is a manufacturing defect?

A manufacturing defect is based on a defect that occurred during the manufacturing process. Many medical device companies have been involved in this kind of product liability lawsuits in recent years.

Most manufacturing defect cases are based on a products deviation from the intended specification, formula, performance standards, or design model. In such cases, it may be easy to determine the product did not comply with the intended design.

The product may be recalled as a specific lot is identified as being non-compliant and defective. A product may be defective in manufacture or construction, materials and assembly, and a manufacturer or distributor may be subject to strict liability, even though it exercised all possible care.  Ohio Revised Code 2307.74.

Does the FDA regulate medical devices?

Design and manufacturing defects result in thousands of product recalls each year in the United States, initiated by the FDA and other federal safety agencies. Following injury and illness, regardless of recall status, victims and plaintiffs may pursue legal action and contact a product liability lawyer to begin the litigation process. Rightful compensation can be sought and help plaintiffs recover medical costs and other related damages.

Product liability law overlaps with regulatory law, which are the systems of legislative rules and administrative agencies, and part of federal and state governments. These agencies regulate the safety of the products sold to the public. Examples include:

The FDA, however, may initiate recalls of dangerous products but does not provide remedies or compensation for damages where an individual is injured due to the defective medical device.

Why should I hire The Lyon Firm?

The Lyon Firm has the experience, resources and dedication to take on difficult and emotional medical device cases and help our clients obtain the justice for the wrong they have suffered. 

Experience:  Joe Lyon is an experienced Cincinnati Defective Device Lawyer. The Lyon Firm has 17 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters. Defective device lawsuits can be complex and require industry experts to determine the root cause of an accident or injury. Mr. Lyon has worked with experts nationwide to assist individuals understand why an injury occurred and what can be done to improve their lives in the future. Some cases may go to a jury trial, though many others can be settled out of court.

Resources/Dedication: Mr. Lyon has worked with experts in the fields of accident reconstruction, biomechanics, epidemiology, metallurgy, pharmacology, toxicology, human factors, workplace safety, life care planning, economics, and virtually every medical discipline in successfully representing Plaintiffs across numerous areas of law. The Lyon Firm is dedicated to building the strongest cases possible for clients and their critical interests.

Results:  Mr. Lyon has obtained numerous seven and six figure results in personal injury and medical device defect cases. The cases have involved successfully litigating against some of  the largest companies in the world.


Learn about Medical Device Approval Processes

Medical Device Settlements

The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against medical device companies due to a defective product or recalled product to obtain just compensation under the law. 



Nationwide Consolidation in U.S. District Court, Northern District of Ohio. The Depuy ASR Hip design was plagued with problems related to premature loosening and metallosis, caused by chromium and cobalt entering the blood stream. The resulting injuries were a result of the metal-on-metal friction inherent with the design of the product. Depuy recalled the ASR and entered into a global settlement valued at $2.5 Billion to cover an estimated 8,000 patients. The Lyon Firm represented several clients in the original settlement and continues to be active in this litigation. The settlement funds provided compensation for the revision surgeries, including compensating for medical costs, lost wages, and pain and suffering.



Nationwide Consolidation in U.S District Court, Northern District of Indiana. Similar to the Depuy ASR, the Biomet metal-on-metal hip design allegedly contributed to premature hip failures and metallosis due to the metal friction. Biomet entered into a global settlement valued at $56 million to cover a few thousand claims. The Lyon Firm represented several plaintiffs in the original settlement and continues to be active in this litigation.