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U.S. Department of Health and Human Services

Class 2 Device Recall Enduramesh Corpectomy Spacer System

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 Class 2 Recall
Enduramesh Corpectomy Spacer System
see related information
Date Posted September 11, 2012
Recall Status1 Terminated on February 20, 2013
Recall Number Z-2368-2012
Recall Event ID 62926
Premarket Notification
510(K) Number
K093207 
Product Classification Spinal Vertebral Body Replacement Device - Product Code MQP
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.
Code Information 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.
Recalling Firm/
Manufacturer
Lucero Medical LLC
6100 Oak Tree Blvd Ste 200
Independence, Ohio 44131-6914
Consumer Instructions No consumer action necessary
For Additional Information Contact Lee S. Strnad
440-465-4321
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQP and Original Applicant = LUCERO MEDICAL, LLC
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