Class II
Medical Device Recall: Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Zimmer Biomet Spine Inc. · October 16, 2023
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of MN, NE.
States Affected
NATIONWIDE
Quantity Affected
3
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0639-2024
Status: ongoing
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