FDA recall Z-0639-2024

Zimmer Biomet Spine Inc. · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2023-10-16
Report date
2024-01-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Westminster, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0639-2024