Reported Jun 9, 2021 · Terminated

ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal…

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 Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.
Lot codes and dates
  • Lot
    • 19123262
    • 20071774
Amount recalled
15 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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Zavation recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

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, 7:00 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.