Description of how price information for each product is disclosed to customers or to their agents

Number of recalls issued; total units recalled

List of products listed in the FDA’s MedWatch Safety Alerts for Human Medical Products database

Number of fatalities related to products as reported in the FDA Manufacturer and User Facility Device Experience

Number of FDA enforcement actions taken in response to violations of current Good Manufacturing Processes (cGMP), by type (including a brief description of the nature, context and any corrective actions taken as a result of any such enforcement actions)

Total amount of monetary losses as a result of legal proceedings associated with false marketing claims

Description of code of ethics governing promotion of off-label use of products

The labeling and promotion of medical devices is regulated in the United States by the Food and Drug Administration (“FDA”). Under FDA regulations and enforcement policies, such products may only be labeled and advertised in a manner consistent with their FDA approved or cleared uses. The Company is committed to following the FDA’s rules and regulations to ensure the safe and effective promotion of the Company’s products. Accordingly, the Company strictly prohibits any promotion of off-label use of its products. Although Healthcare Professionals (“HCPs”) can legally use medical device products for any use that they determine is in the best interests of their patients, Company employees and representatives are prohibited from supporting an HCP’s decision to do so or stating or implying that an HCP may disregard any warning, contraindication or precaution contained in product labeling. Company employees receive regular training on how to avoid off-label promotion of products.

Discussion of process to assess and manage environmental and human health considerations associated with chemicals in products, and meet demand for sustainable products

Many of our products are medical devices subject to extensive regulation by the FDA in the United States and other regulatory bodies abroad. We are committed to reducing the environmental impact of our products and encourage our teams to look for ways to safely reduce the amount of materials required to manufacture, package and ship our products. In addition, as part of our regular product development and design activities, we evaluate the chemicals and materials used in our products and pursue opportunities to utilize safe and sustainable alternatives.

Total amount of products accepted for takeback and reused, recycled, or donated, broken down by: (1) devices and equipment and (2) supplies

Many of our medical devices are single use or implantable and are thus unable to be re-used or recycled. However, when possible, we seek out opportunities to recycle products at the end of their lifecycle and make the process easier for our customers and patients. As an example, our CMF OL 1000 bone growth stimulators are not reusable (FDA approved single patient use) and cannot be re-sold.

However, when treatment is complete, we offer patients a prepaid shipping label to return the device so that it can be properly disposed of to help reduce landfill waste. We do not currently report the total amount of product takeback.

Percentage of (1) entity’s facilities and (2) Tier I suppliers’ facilities participating in third-party audit programs for manufacturing and product quality

Description of efforts to maintain traceability within the distribution chain

Total amount of monetary losses as a result of legal proceedings associated with bribery or corruption

Description of code of ethics governing interactions with healthcare professionals

The Company is committed to following the highest ethical standards as well as all legal requirements in its interactions with the medical community. In addition to the obligations set forth in the Code, the Company maintains a separate Relationships with Healthcare Providers policy, which mandates that all interactions with HCPs must be consistent with ethical business practices and socially responsible industry conduct. Towards that end, the Company also follows the AdvaMed Code of Ethics. The Company is also committed to compliance with rules on Transparency Reports and Reporting of Physician Ownership or Investment Interests promulgated by the Centers for Medicare and Medicaid Services (the “Physician Payments Sunshine Act”), and requires that all transfers of value with HCPs and CMS-designated teaching hospitals that are reportable under the Physician Payments Sunshine Act or other applicable transparency laws are appropriately captured and reported.