Zimmer has temporarily suspended distribution of its Trilogy acetabular hip devices from its Puerto Rico facility following an FDA warning letter regarding its manufacturing practices, according to a
Mass Device report.
According to the letter, the company lacked a testing protocol to ensure all devices met pre-determined design specifications and failed to validate the effect of manufacturing operations that incorporate metallic spikes into Trilogy devices.
As a result, the Puerto Rico facility has been temporarily closed as Zimmer works to implement the FDA-mandated processes.
More Articles on Orthopedic Devices:
8 New Orthopedic & Spine Device Launches
Mazor Robotics Finalizes Financing Agreement for Up To $15M
Spinal Elements to Launch Hero Allograft 
