Reported Jun 13, 2018 · Terminated

VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit

VGI Medical, LLC

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: VGI Medical, LLC · 10401 Belcher Rd S · Seminole, FL · 33777-1415

Is this the product you have?

  • VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
Lot codes and dates
  • Lots of Instrument Sets
    • LP-INSTSET-001
    • VLP-INSTSET-002
    • VLP-INSTSET-003
    • VLP-INSTSET-004
    • VLP-INSTSET-005
    • VLP-INSTSET-006. Lots of individual
  • instruments contained in sets
    • 127617
    • 127901
    • 127902
    • 127903
    • 127904
    • 127905
    • 127906
    • 127907
    • 127908
    • 133003
    • 133004
    • 133005
    • 1330-1
    • 1330-2
    • 1330-6
    • 133004
    • 1285001
    • 144301
    • 144302
    • 163214
    • 1401001
    • 157801
    • 162402 163203
    • 163204
    • 163205
    • 163206
    • 163207
    • 163208
    • 163209
    • 163212
    • 163213
    • and 163214
Amount recalled
6 units

Where it was sold

Why it was recalled

IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated

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 Aug 21, 2020 · Data as of Sep 19, 7:32 PM UTC

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