FDA-Device2024-01-10Class II
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Zimmer Biomet Spine Inc.
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.
Sold states
US Nationwide distribution in the states of MN, NE.
Affected count
3
Manufactured in
10225 Westmoor Dr, N/A, Westminster, CO, United States
Products
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0639-2024Don't want to check this manually?
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