ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic / spinal procedures.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 13978ZV, 13966ZV, 13873ZV, 13643ZV, 13185ZV, 12594ZV, 11766ZV, 11548ZV, 11391ZV, 11139ZV, 10781ZV, 14390ZV, 13976ZV, 13711ZV, 13413ZV, 12930ZV, 12331ZV, 12300ZV, 12199ZV, 14349ZV, 11271ZV, 11847ZV, 11274ZV
  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 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic / spinal procedures.

Product Codes/Lot Numbers:

Lot Numbers: 13978ZV, 13966ZV, 13873ZV, 13643ZV, 13185ZV, 12594ZV, 11766ZV, 11548ZV, 11391ZV, 11139ZV, 10781ZV, 14390ZV, 13976ZV, 13711ZV, 13413ZV, 12930ZV, 12331ZV, 12300ZV, 12199ZV, 14349ZV, 11271ZV, 11847ZV, 11274ZV

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1765-2021

Related Recalls