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Zimmer Biomet Spine Inc. recalls Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Recalled January 10, 2024 · FDA recall Z-0639-2024 · Zimmer Biomet Spine
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. · FDA Class II
Units
3
Sold at
US Nationwide distribution in the states of MN, NE.
Description
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.
Product
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Manufacturer(s)
Zimmer Biomet Spine Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →