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Terminated

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.

FDA Recall Z-1059-2012 · Posted 2012-02-17

Recalling FirmLucero Medical LLC
Recall StatusTerminated
Product CodeMQP
Date Initiated2012-01-11
Date Terminated2014-04-11
Product Quantity190 units

Reason for Recall

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.

Firm 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

Root Cause

Device Design

Distribution Pattern

USA Nationwide Distribution - in the state of OH.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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