Reported Jun 9, 2021 · Terminated

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

Zavation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zavation · 220 Lakeland Pkwy · Flowood, MS · 39232-9552

Is this the product you have?

  • ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic / spinal procedures.
Lot codes and dates
  • 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
Amount recalled
302 units

This recall covers 71 products

The agency filed one notice per product. You are reading one of them; the other 70 are below.

58 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Products distributed as sterile may not have been adequately sterilized

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 20, 2023 · Data as of Sep 19, 5:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.