FDAFDA · Food and drugs·Recall number Z-0846-2024
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Published February 7, 2024 · Recall initiated: November 28, 2023
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
Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- XTANT Medical Holdings, Inc
- Distributor
- US distribution in MI.
- Lot
- UDI-DI: 00810076564005, Lot: AP23000143
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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