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FDAOctober 16, 2023device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

zimmer biomet spinezimmerzimmer biomet

UPCs

00889024002159

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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