Reported Sep 19, 2012 · Terminated

Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for…

Lucero Medical LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lucero Medical LLC · 6100 Oak Tree Blvd Ste 200 · Independence, OH · 44131-6914

Is this the product you have?

Enduramesh
Corpectomy Spacer System Product UsageThe 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

Lot codes and dates: 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
Amount recalled: 169

Where it was sold

Nationwide

Why it was recalled

The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation.

This product could cause temporary or reversible health problems — stop using it.

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