Z-2368-2012Class II

Enduramesh Corpectomy Spacer System

Name: Z-2368-2012 Enduramesh Corpectomy Spacer System
Creator: Lucero Medical LLC
Published: 2012-07-15
License: https://open.fda.gov/license/

Lucero Medical, LLC / initiated 2012-07-15 / Terminated / root cause: labeling and UDI

FDA source

Lucero Medical LLC began a recall of Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine... on 2012-07-15. FDA classified it as Class II and gives the reason as "The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2368-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-15
Posted: 2012-09-11
Terminated: 2013-02-20
Recalling firm: Lucero Medical, LLC
Product: Enduramesh Corpectomy Spacer System Product Usage: 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 autograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.
Product code: MQP Spinal Vertebral Body Replacement Device
Reason for recall: The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Lucero Medical sent a Field Correction Notice letter dated July 15, 2012 to it's sole consignee. The notice identified the affected product., problem and actions to be taken. The customer was instructed to complete the response card and submit back to their local Lucero Medical Representative.
Quantity in commerce: 169
Distribution: US Nationwide Distribution
Product codes and lots: Part #-Lot # (s): 762.010L-110738; 762.013L-110738; 762.017L-60611, 90611, and 512171; 762.019L-60611, 90611, 100308, 1261901, and 20121901; 762.021L-60611, 90611, 100308, 110106, 20122101, and 20122102; 762.023L- 90611, 100209, 100218, 00706, 10709, 20122301, and 20122302; 762.025L-90611, 100218, 110106, 20122501, and 20122502; 762.027L-60611, 90611, 100706, and 20122071; 762.029L-90611, 1262901, and 90611; 762.031L-1263101; 762.033L-90611, 91002, and 1263301; 762.041L-90611 and 1264101; 762.043L-90611 and 1264301; 762.045L-90611; 762.047L-90611; 762.049L-90611; 762.051L-90611 and 512511; 762.053L-90611; 762.090L-90611; 762.090L-2.0-100206 and 100342; 762.090L-2.5-100206; 762.159L-110505; 762.237L-91002; 762.243L-91018; 762.270L-91018; 762.290L-91018; 762.731L-91018; 762.735L-91002; 762.767L-91018; and 762.790L-91018.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2368-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2368-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-11

Product code MQP

K093207Class IIEnduramesh, Model 762.XxxLucero Medical, LLC / cleared 2010-04-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)