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-001VLP-INSTSET-002VLP-INSTSET-003VLP-INSTSET-004VLP-INSTSET-005VLP-INSTSET-006. Lots of individual
- instruments contained in sets
1276171279011279021279031279041279051279061279071279081330031330041330051330-11330-21330-613300412850011443011443021632141401001157801162402 163203163204163205163206163207163208163209163212163213and 163214
- Lots of Instrument Sets
- 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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