VGI Medical VerteLP Instrument Kit Recalled for Unvalidated Cleaning Process
VGI Medical is recalling six VerteLP Lateral Interbody Fusion instrument kits because the included cleaning process was not validated.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves an unvalidated cleaning process, which is a procedural defect rather than a direct structural failure or reported injury, fitting the Moderate criteria for low-risk contamination or procedural issues without reported harm.
Plain-English summary
VGI Medical, LLC is recalling six units of the VerteLP Lateral Interbody Fusion instrument kit. The recall was initiated because the instruction for use (IFU) contained an automated cleaning process for the VerteLP Instrument Tray that was not validated.
The affected instrument sets include lots LP-INSTSET-001, VLP-INSTSET-002, VLP-INSTSET-003, VLP-INSTSET-004, VLP-INSTSET-005, and VLP-INSTSET-006. The kits were distributed to facilities in Michigan, Florida, and New York.
Healthcare facilities should stop using the affected instrument kits and contact VGI Medical for further instructions regarding the unvalidated cleaning process.
The recalled product
- Product
- VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
- Manufacturer
- VGI Medical, LLC
- Hazard
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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