FDAFDA · Food and drugs·Recall number Z-0639-2024
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Published January 10, 2024 · Recall initiated: October 16, 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 system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet Spine Inc.
- Distributor
- US Nationwide distribution in the states of MN, NE.
- Lot
- UDI-DI: 00889024002159, Lot: W834061
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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