medical Class II Updated 2024-01-10

Zimmer Biomet Spine Inc. recalls Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, us

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00889024002159, Lot: W834061
View official government recall

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