Dive Brief:

• Advita Ortho, a Gainesville, Florida-based orthopedics firm, received a warning letter from the Food and Drug Administration in December related to its Equinoxe Reverse Shoulder System.
• The FDA posted the warning letter on Tuesday. The warning letter detailed the need to define product specifications for components of the shoulder implant and a lack of environmental controls. 
• Advita Ortho was formed in November by a group of investors who bought Exactech’s assets after it filed for Chapter 11 bankruptcy. Exactech recalled its shoulder implants and received a warning letter in 2024 over defective packaging, which could lead to accelerated device wear or failure.

Dive Insight:

The FDA sent the warning letter after an inspection of Exactech’s Sarasota, Florida, facility in July. At the time of the inspection, Exactech had not yet received court approval to sell its assets and Advita Ortho had not yet been launched.

The warning called out a lack of specifications and instructions for manufacturing the orthopedic products. For example, FDA inspectors said the company failed to define certain specifications and testing for polymer powder that was fabricated into polyethylene-molded products. The company did not audit an outside supplier of powder to make sure it was meeting product specifications.

The Sarasota facility also lacked work instructions outlining production and processing controls for the Equinoxe Torque Screw and its Equinoxe Shoulder Liner devices. In one case, an operator passed a screw through inspection that should not have passed, based on measurements reviewed by FDA inspectors.

The warning letter also found that between July 2023 and July 2025, Exactech had incomplete documentation maintained or available for production events, or instances where a product deviated from process specifications, to keep track of which ones were managed as nonconformances.

Finally, the letter raised concerns about a lack of environmental control at the facility. From March 2024 to the time of the letter, monitoring data showed the site continued to exceed allowable temperature and humidity data. The temperature specifications were changed last year after historical data showed consistent excursions, the FDA inspectors wrote. High moisture may affect the strength of materials used in devices. 

The warning letter follows previous product quality issues at Exactech, which in September agreed to pay $8 million to settle allegations that it violated the False Claims Act by selling defective knee implants.