Precice Max Femur Implant (NuVasive) – Design and Manufacturing Issue (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.

Recommended Action

Per FDA guidance

On 9/30/2024, the firm sent an "URGENT: Medical Device Recall Notification" letter via FedEx to customers informing them that Globus Medical is investigating potential issues with the design, manufacturing, and documentation related to the validation associated with the Precice Max manufactured by NuVasive Specialized Orthopedics (NSO). Customers are instructed to: Monitor their patients closely for any potential adverse events and to stop/cease use of device that have not been implanted and immediately return all remaining Precice" Max devices and complete the attached Response Form and send it by FAX: 1-610-300-1342 or Email:recall@globusmedical.com. Contact Globus Customer Service at 1-866-456-2871 for Return Authorization. Contact your local Globus Sales Representative to coordinate the return of the Precice Max Device(s). For recall related questions and support contact: Globus Medical Complaint Handling Unit by Fax: 610-300-1342 or Email: recall@globusmedical.com.

Distribution

As reported by FDA

FL, NV