Lucero Medical LLC: ENDURAMESH CORPECTOMY SPACER SYSTEM 013MM, 017MM, 023MM by varying heights. Dist. By: Lucero Medical, PO Box 67, Richfield, Ohio 44826 Product Usage: Device Description: The Enduramesh is a vertebral body replacement system which provides structural support of the vertebral bodies following an anterior or far lateral corpectomy, aiding in spinal fusion. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference. The Enduramesh vertebral body replacement system consists of a single cylindrically shaped titanium mesh cage. The hollow core of the cage allows for packing bone graft and the circular holes throughout the device promote bone fusions. Various diameters and heights are available to accommodate variability among patients. Indications for Use: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autoograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.

Recall number

Z-1059-2012

Recalling firm

Lucero Medical LLC

Product

ENDURAMESH CORPECTOMY SPACER SYSTEM 013MM, 017MM, 023MM by varying heights. Dist. By: Lucero Medical, PO Box 67, Richfield, Ohio 44826 Product Usage: Device Description: The Enduramesh is a vertebral body replacement system which provides structural support of the vertebral bodies following an anterior or far lateral corpectomy, aiding in spinal fusion. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference. The Enduramesh vertebral body replacement system consists of a single cylindrically shaped titanium mesh cage. The hollow core of the cage allows for packing bone graft and the circular holes throughout the device promote bone fusions. Various diameters and heights are available to accommodate variability among patients. Indications for Use: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autoograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.

Status

Terminated

Initiated

2012-01-11

Posted

2012-02-17

Terminated

2014-04-11

Reason

During an FDA inspection the firm was informed that the device marketed is not the device cleared for the 510K associated with the device. The product is sold unlabeled.

Root cause

Device Design

Action

Lucero Medical LLC made a personal visit to facilities in regards to an Urgent Medical Device Recall as of January 12, 2012. The firm instructed the customer that they were removing and quarantining all product from the facility. If you have any further questions, please contact Lucero Medical, PO Box 69, Richfield, Ohio 44826, Director of Quality Assurance/Natalie Williams/ (440) 670-9583

Quantity

190 units

Distribution

USA Nationwide Distribution - in the state of OH.

Lot, serial or model codes

Part # 762.010, Lot # 110738; Part # 762.019, Lot # 90611, Lot #, 100308; Part # 762.021, Lot # 100308, Lot #, 110106; Part # 762.023, Lot # 90611, Lot # 100218, Lot # 100706, Lot # 110709; Part # 762.025, Lot # 90611, Lot # 100218, Lot #, 110106; Part # 762.027, Lot # 100706; Part # 762.029, Lot # 90611; Part # 762.033, Lot # 90611, Lot # 91002; Part # 762.041, Lot # 90611; Part # 762.043, Lot # 90611; Part # 762.045, Lot # 90611; Part # 762.047, Lot # 90611; Part # 762.049, Lot # 90611; Part # 762.051, Lot # 90611; Part # 762.053, Lot # 90611; Part # 762.090-2.0, Lot # 100206; Part # 762.090-2.5, Lot # 100206; Part # 762.237, Lot # 91002; Part # 762.243, Lot # 91018; Part # 762.270, Lot # 91018; Part # 762.290, Lot # 91018; Part # 762.731, Lot # 91018; Part # 762.735, Lot # 91002; Part # 762.767, Lot # 91018 & Part # 762.790, Lot # 91018.

510(k) numbers

not on file

PMA numbers

not on file

Product code

MQP

Firm FEI

3008775608

Firm city

Hinckley

Firm state

OH

Firm country

not on file

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

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