🔍 RecallPedia

ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.

Class I - Dangerous
🏥 Medical Devices Recalled: March 25, 2021 Zavation Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    a) VCF-1015-2, Lot Numbers: 13814ZV, 10950ZV, 11694ZV, 10953ZV, 10779ZV, 10588ZV, 13664ZV, 13469ZV, 13519ZV, 10825ZV, 13885ZV, 12989ZV, 10933ZV, 13758ZV, 14107ZV, 14206ZV, 14680ZV, 14022ZV, 11603ZV, 10505ZV b) VCF-1015-2A, Lot Numbers: 10515ZV, 14197ZV, 14114ZV, 14113ZV, 14024ZV, 14023ZV, 13641ZV, 13471ZV, 13325ZV
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Zavation
Reason for Recall:
Products distributed as sterile may not have been adequately sterilized
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.

Product Codes/Lot Numbers:

a) VCF-1015-2, Lot Numbers: 13814ZV, 10950ZV, 11694ZV, 10953ZV, 10779ZV, 10588ZV, 13664ZV, 13469ZV, 13519ZV, 10825ZV, 13885ZV, 12989ZV, 10933ZV, 13758ZV, 14107ZV, 14206ZV, 14680ZV, 14022ZV, 11603ZV, 10505ZV b) VCF-1015-2A, Lot Numbers: 10515ZV, 14197ZV, 14114ZV, 14113ZV, 14024ZV, 14023ZV, 13641ZV, 13471ZV, 13325ZV

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1762-2021

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