FDA EIR - Exactech, Inc. - November 17, 2021

An FDA inspection of Exactech, Inc. in Gainesville, FL, was conducted from November 8 to November 17, 2021. This targeted inspection focused on the company's Class II and III orthopedic implants, operating under the Food, Drug, and Cosmetic Act, and aimed to review two specific field corrective actions. The inspection resulted in four observations documented on an FDA-483 form, indicating deficiencies in design transfer activities, process validation, acceptance processes, and the statistical justification for sampling plans. Company management pledged to address these observations. Key issues included early wear in GXL hip liners (RES 88126), attributed to factors like surgical technique and material susceptibility. Exactech responded by phasing out these liners and issuing urgent medical device corrections and professional advisories. A second critical issue (RES 88570) involved non-conforming vacuum packaging bags, lacking an oxygen barrier, which affected several implant lines. Investigations revealed both supplier non-compliance and Exactech's inadequate incoming material inspection. Consequently, Exactech is recalling specific Knee and Ankle UHMWPE products with an 8-year shelf life, issuing professional notifications, and has revised its supplier quality management procedures.