Stryker (SYK) Risk Factor Changes
Stryker Risk Factor Changes
Latest 10-K compared with the year before. 926 changes found.
reimbursement levels from third-party payors in the United States
interruptions, damage to our products and facilities as well as the infrastructure of hospitals, medical care facilities and other customers, reduced workforce availability, increased costs of raw materials and compon…
Dollar amounts in millions except per share amounts or as otherwise specified.
Physical effects of climate change or legal, regulatory or market measures intended to address climate change could adversely affect our operations and operating results: Risks associated with climate change are subje…
We could be negatively impacted by corporate responsibility and sustainability-related matters: Governments, investors, customers, employees and other stakeholders have been focused on corporate responsibility practic…
factors, including operating requirements, current and future acquisitions and the need to refinance existing debt.
Additional capital that we may require in the future may not be available to us or may only be available to us on unfavorable terms, which could negatively affect our liquidity: Our future capital requirements will de…
We have exposure to exchange rate fluctuations on cross border transactions and translation of local currency results into United States Dollars: We report our financial results in United States Dollars and approximat…
Dependence on intellectual proprietary rights and failing to protect such rights or to be successful in litigation related to such rights may impact offerings in our product portfolios: Our long-term success largely d…
Intellectual property litigation and infringement claims could cause us to incur significant expenses or prevent us from selling certain of our products: The medical device industry is characterized by extensive intel…
Statements.
We may be adversely affected by product liability claims, unfavorable court decisions or legal settlements: We are exposed to potential product liability risks inherent in the design, manufacture and marketing of medi…
We are subject to privacy, data protection and data security regulations and laws globally, and could face substantial penalties if we fail to comply with such regulations and laws: We are subject to a variety of laws…
the past resulted and could in the future result in investigations, litigation or government proceedings, and we have been and may in the future be subject to criminal or civil penalties and sanctions, including subst…
We are subject to federal, state and foreign healthcare regulations, including anti-bribery, anti-corruption, anti-kickback and false claims laws, globally and could face substantial penalties if we fail to comply wit…
We are subject to extensive governmental regulation relating to the classification, manufacturing, sterilization, licensing, labeling, marketing and sale of our products: The classification, manufacturing, sterilizati…
products’ coverage or reimbursement, or make changes to patient access to healthcare, all of which could adversely impact the demand for and usage of our products or the prices that our customers are willing to pay fo…
The impact of healthcare reform legislation on our business remains uncertain: Several markets where we sell our products are making efforts to expand access to healthcare or health insurance coverage while decreasing…
We could be negatively impacted by future changes in the allocation of income to each of the income tax jurisdictions in which we operate: We operate in multiple income tax jurisdictions both in the United States and…
Current economic and political conditions make tax rules in jurisdictions subject to significant change: Our future results of operations could be affected by changes in the effective tax rate as a result of changes i…
distribute or use our products or provide required services.
Pandemics and public health emergencies, and the fear thereof, have in the past materially adversely affected and could in the future materially adversely affect, our operations, supply chain, manufacturing, product d…
Our use of AI and other emerging technologies could adversely impact our business and financial results: We have begun to deploy AI and other emerging technologies in various facets of our operations and we continue t…
Unpredictable increases in demand for certain of our products have exceeded in the past, and could exceed in the future, our capacity to meet such demand timely, which could adversely affect our customer relationships…
governmental authorities: Some of our products are particularly sensitive to reductions in elective medical procedures.
We have experienced, and may continue to experience, a significant and unpredictable need to adjust our operations as market demand for certain of our products has shifted and continues to shift or as may be mandated by
Our insurance program may not be adequate to cover future losses: We maintain third-party insurance to cover our exposure to certain property and casualty losses and are self-insured for claims and expenses related to…
Interruption of manufacturing operations could adversely affect our business: We and our suppliers have manufacturing and supply sites all over the world.
Effective succession planning is also important to our long-term success.
may harm our culture and/or decrease employee engagement, which could adversely impact our ability to recruit, hire, develop and retain a talented, competitive workforce.
We may be unable to attract, develop and retain executives and key employees: Our sales, technical and other key personnel play an integral role in the development, marketing and selling of new and existing products.
An inability to successfully manage the implementation of our new commercial global enterprise resource planning (ERP) system could adversely affect our operations and operating results: We are in the process of imple…
If our IT systems, networks or processes are damaged or cease to function properly for any reason, the networks, service providers, hardware or software we rely upon fail to function properly, or we or one of our thir…
approach to protect against exploitation, which may not be effective.
Hardware and software failures or delays in our key information technology systems, networks, processes or sites could disrupt our operations, cause the loss of confidential information or otherwise adversely impact o…
When cybersecurity or other technology related incidents occur, we follow our incident response protocols and address them in accordance with applicable governmental regulations and other legal requirements.
phishing narratives, spread disinformation about us or our products or otherwise strengthen social engineering capabilities.
We, our business partners or our third-party vendors could experience a material failure or breach of a key information technology system, network, process or site: We rely extensively on information technology (IT) s…
We may be unable to capitalize on previous or future acquisitions: In addition to internally developed products, we invest in new products and technologies through acquisitions.
the European Union Medical Device Regulation (MDR) through December 2028); differing local product preferences and product requirements; diminished protection of intellectual property in some countries; tariffs and ot…
We are subject to risks associated with our extensive global operations: We develop, manufacture and distribute our products globally.
We rely on indirect distribution channels and major distributors that are independent of Stryker: In many markets we rely on indirect distribution channels to market, distribute and sell our products.
We may be unable to maintain adequate working relationships with healthcare professionals: We work with healthcare professionals in a transparent and responsible manner and seek to maintain these relationships with re…
We operate in a highly competitive industry in which competition and the regulatory burden in the development and improvement of new and existing products is significant: The markets in which we compete are highly com…
We are subject to pricing pressures as a result of cost containment measures in the United States and other countries and other factors, including changes in reimbursement practices and coverage policies and third-par…
In addition, in recent years, the market has experienced inflationary pressures in part due to global supply chain disruptions, labor shortages and other impacts following the COVID-19 pandemic.
We use a variety of raw materials, components, devices and third-party services in our global supply chains, production and distribution processes; significant shortages, price increases or unavailability of third-par…
Our operations and financial results are subject to various risks and uncertainties discussed below that could materially and adversely affect our business, cash flows, financial condition and results of operations.
contained in this report are qualified in their entirety by this cautionary statement.
While we believe that the assumptions underlying such forward-looking statements are reasonable, there can be no assurance that future events or developments will not cause such statements to be inaccurate.
•other risks detailed in our filings with the SEC.
•the effects of the proposed Inari transaction (or the announcement thereof) on the parties’ relationships with employees, customers, other business partners or governmental entities; and
•unexpected liabilities, costs, charges or expenses in connection with the acquisition of Inari;
•delays in consummating the acquisition of Inari or the risk that the transaction may not close at all;
•the failure to satisfy any of the closing conditions to the acquisition of Inari, including the expiration or termination of the Hart-Scott-Rodino Antitrust Improvements Act waiting period (and the risk that such gov…
•uncertainties as to how many of Inari’s stockholders will tender their shares in the tender offer;
•uncertainties as to the timing of the tender offer for shares of Inari common stock and the subsequent merger with Inari;
•the impact on our operations and financial results of any public health emergency and any related policies and actions by governments or other third parties;
•potential negative impacts resulting from climate change or other environmental, social and governance and sustainability related matters;
•our ability to realize any anticipated cost savings;
•our ability to integrate and realize the anticipated benefits of acquisitions in full or at all or within the expected timeframes, including our acquisition of Inari;
•costs to comply with medical device regulations;
•the impact of legislation to reform the healthcare system in the United States or other countries;
•the impact of investigative and legal proceedings and compliance risks;
•the ultimate total cost with respect to recall-related and other regulatory and quality matters;
•a significant increase in product liability claims;
•breaches, failures or other disruptions of our or our vendors’ or customers’ information technology systems or products, including by cyber-attack, data leakage, unauthorized access or theft;
•changes in the competitive environment;
•increased interest rates or interest rate volatility;
•unanticipated issues arising in connection with clinical studies and otherwise that affect approval of new products, including Inari products, by the FDA and foreign regulatory agencies;
•changes in foreign currency exchange markets;
•pricing pressures generally, including cost-containment measures that have adversely affected and could in the future adversely affect the price of or demand for our or Inari’s products;
•geopolitical risks, including from international conflicts, which could, among other things, lead to increased market volatility;
•weakening of economic conditions, or the anticipation thereof, that could adversely affect the level of demand for our or Inari Medical, Inc.’s (“Inari”) products;
This report contains statements that are not historical facts and are considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.
distribution activities or operating results.
otherwise adversely affect our manufacturing, supply chain,
availability and sourcing, require operational changes, or
increase compliance costs, create uncertainty, affect raw material
of environmental laws and regulations.
through the adoption, modification, interpretation, or enforcement
evolve, differ by jurisdiction, or change over time, including
Regulatory requirements and enforcement approaches may
be the subject of regulatory, legal and market attention.
operations.
customers, any of which could negatively impact our results of
operations of hospitals, medical care facilities and other
and component costs, increase liabilities, or adversely affect the
distribution, reduce workforce availability, increase raw material
products, or those of our suppliers, disrupt manufacturing and
and other natural disasters, could damage our facilities and
tornadoes, wildfires, droughts, extreme temperatures, flooding,
and infrastructure disruptions.
environmental conditions may result in operational, supply chain
and operating results: Weather-related events and evolving
sustainability matters, could adversely affect our operations
market measures related to environmental, climate and other
Physical weather events, as well as legal, regulatory or
and/or actions with respect to corporate responsibility matters are
investors and other stakeholders may conclude that our policies