Device product
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
Z-2100-2018
Product summary
- Firm
- VGI Medical, LLC
- Event
- Event 80012
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-2100-2018
Official wording
Reason: IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated
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.
Distribution pattern: Distributed to MI, FL, and NY.
Derived failure modes
-
Manufacturing or process control
cleaning process for the VerteLP Instrument Tray that was not validated