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Recall Observatory FDA recall evidence

Device product

Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System

Z-0639-2024

October 16, 2023

Class II

Product summary

Firm
Zimmer Biomet Spine Inc.
Event
Event 93650
Status
Ongoing
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-0639-2024

Official wording

Reason: 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.

Code information: UDI-DI: 00889024002159, Lot: W834061

Distribution pattern: US Nationwide distribution in the states of MN, NE.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.