Z-2100-2018 Class II Terminated
FDA device recall Z-2100-2018 was initiated by VGI Medical, LLC on April 9, 2018 and is designated Class II. Reason for recall: IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated The recall status is terminated (terminated August 21, 2020). Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 13, 2018
- Initiation Date
- April 9, 2018
- Termination Date
- August 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
Reason for Recall
IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated
Distribution Pattern
Distributed to MI, FL, and NY.
Code Information
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.