Zimmer Biomet Spine Inc.: Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System

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.

Details from the source

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. Quantity: 3 Lot/code info: UDI-DI: 00889024002159, Lot: W834061

UPC codes

00889024002159

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.