Recall Z-2100-2018
VGI Medical, LLC · initiated April 9, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
Codes / lots: 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.
Reason for recall
IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated
FDA-determined cause: Process design
Action taken
The firm notified their direct consignees by letter on 04/09/2018 and followed with an e-mail on 04/11/2018. The letter directed the direct consignees (distributors) to instruct their accounts (user) to discontinue the automated cleaning process and to provide users with the new IFUs.
Details
- Recall number
- Z-2100-2018
- Initiated
- April 9, 2018
- Terminated
- August 21, 2020
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Quantity
- 6 units
- Distribution
- Distributed to MI, FL, and NY.
- Recalling firm
- VGI Medical, LLC, Seminole, FL