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

Class I - Dangerous

🏥 Medical Devices Recalled: October 16, 2023 Zimmer Biomet Spine Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
UDI-DI: 00889024002159, Lot: W834061
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Zimmer Biomet Spine Inc.
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

UDI-DI: 00889024002159, Lot: W834061

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0639-2024

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