Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

Exactech recalls shoulder devices

In 2021, Exactech initiated a recall due to premature wear in hip replacement products, later identifying defective packaging lacking an essential oxygen barrier layer. The FDA advised against implanting Exactech’s knee, ankle, and hip devices in March 2023.

In January, the FDA highlighted that Exactech had sold Equinoxe shoulder devices without the necessary barrier layer from 2004 to 2021. Despite the FDA's caution, Exactech initially refrained from recalling these devices. However, following a warning letter from the FDA, Exactech promptly advised customers to monitor patients with the affected shoulder systems.

In a March communication, Exactech underscored that oxidation could hasten device wear or failure, potentially necessitating revision surgery. They also conveyed the FDA's recommendation for surgeons to consider X-rays if device failure is suspected.

The recall covers devices manufactured between 2004 and August 2021, with over 120,000 affected devices sold until February 15, 2024. Exactech assured customers of continued service without disruption.