Ship Hold Lifted for NuVasive’s Titanium-Based Precice Devices

The U.S. Food and Drug Administration (FDA) has been monitoring possible biocompatibility issues affecting NuVasive Specialized Orthopedics’ Precice limb-lengthening devices made from stainless steel and titanium. On Dec. 1, the FDA issued updated information and recommendations about the titanium-based Precice devices.
 
The company released a field safety notice Nov. 30 indicating updated labeling and the shipping hold in the U.S. was lifted for the titanium-based devices. NuVasive also issued a recall to inform users of the updated labeling for the Precice Freedom, Intra-medullary Limb Lengthening Device, Short, and Unyte products.
 
FDA claims the overall device benefits outweigh risks for on-label use with updated labeling compared to other treatment. The Instructions for Use for titanium-based Precice devices have been updated for clarification that they’re intended for adults, patients should weigh over 50 lbs. or more during treatment, and no more than two devices should be simultaneously implanted.
 
The company advised patients currently under 50 lbs. and/or with over two devices implanted should have their healthcare team assess treatment progression and consider nail removal promptly at the end of treatment. This may minimize potential risks and those associated with repeated interventions and conversion to alternative therapies during treatment.
 
FDA isn’t currently aware of adverse events related to biocompatibility problems with the devices. NuVasive is investigating the root cause of the issues, and examining how they may relate to titanium-based devices.
 
This past April, NuVasive issued a statement about ongoing Precice biocompatibility testing and placed a worldwide ship hold on all Precice devices. FDA is working with the company to evaluate biocompatibility assessments and collect data to better understand patient risks.