Recall Z-2100-2018 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
VGI Medical, LLC
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
| Date | Apr 9, 2018 |
| Status | Terminated |
| Reason | IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated |
| Root cause | Process design |
| Action | 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. |
| Quantity | 6 units |
| Distribution | Distributed to MI, FL, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151312 | VerteLP Interbody Fusion Device Vgi, LLC, Jan 13, 2016 |