FDAFDA · Food and drugs·Recall number Z-1616-2024
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716
Published May 1, 2024 · Recall initiated: March 22, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- EBI, LLC
- Distributor
- US Nationwide distribution.
- Lot
- UDI-DI: 00812301020218 All devices distributed since May 1, 2023
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.