Exactech Orthopedic Implant Recall Litigation

In 2022, orthopedic device manufacturer Exactech issued one of the largest joint implant recalls in U.S. history, affecting over 147,000 knee, hip, and ankle replacement devices. The recall stemmed from the use of out-of-specification polyethylene packaging bags that failed to prevent oxygen infiltration, causing the implant components to oxidize and degrade prematurely — often while still inside patients' bodies. This degradation led to accelerated wear, implant loosening, bone loss, and severe pain, forcing thousands of patients to undergo complex and painful revision surgeries to remove and replace the failed devices.

Plaintiffs in this MDL allege that Exactech knew or should have known about the packaging defect for years before issuing the recall, and that the company prioritized profits over patient safety by continuing to sell the defective products. Claims include strict products liability, negligence, breach of warranty, and failure to warn. The litigation is particularly impactful because many affected patients are elderly individuals who face heightened surgical risks with revision procedures. The MDL has grown rapidly and is considered one of the most significant medical device litigations of the 2020s.