CLASS II Device recall · Reported 13 Jun 2018 · FDA Enforcement Report
VerteLP Lateral Interbody Fusion instrument kit recalled by VGI Medical
VGI Medical is recalling VerteLP Lateral Interbody Fusion instrument kit, distributed in Florida, Michigan, New York. The recall was initiated on 9 Apr 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2100-2018
- FDA event ID
- 80012
- Recalling firm
- VGI Medical, Seminole, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Apr 2018
- FDA classified
- 5 Jun 2018
- Reported
- 13 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 9 Apr 2018 | Recall initiated by company | |
| 5 Jun 2018 | Classified by FDA | +57 days |
| 13 Jun 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated
Product as listed by the FDA
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
Where it was distributed
Distributed to MI, FL, and NY.
Questions about this recall
Why was it recalled?
IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated
Which lots are affected?
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.
Where was it sold?
Distributed to MI, FL, and NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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