FDA Medical Device Recalls (openFDA)
VGI Medical, LLC: VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
- Recall number
- Z-2100-2018
- Recalling firm
- VGI Medical, LLC
- Product
- VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
- Status
- Terminated
- Initiated
- 2018-04-09
- Posted
- not on file
- Terminated
- 2020-08-21
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- K151312
- PMA numbers
- not on file
- Product code
- OVD
- Firm FEI
- 3006982954
- Firm city
- Seminole
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28