Class 2 Device Recall ENDURAMESH CORPECTOMY SPACER SYSTEM

• Date Initiated by Firm: January 11, 2012
• Date Posted: February 17, 2012
• Recall Status: Terminated on April 11, 2014
• Recall Number: Z-1059-2012
• Recall Event ID: 60972
• Product Classification: Spinal vertebral body replacement device - Product Code MQP
• 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Lucero Medical LLC; 400 Wakefield Run Blvd; Hinckley OH 44233-9251
• For Additional Information Contact: 440-821-7744
• Manufacturer 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.
• FDA Determined 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 in Commerce: 190 units
• Distribution: USA Nationwide Distribution - in the state of OH.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.