FDA-Device2012-09-19Class II
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.
Lucero Medical LLC
Hazard
The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation.
Sold states
US Nationwide Distribution
Affected count
169
Manufactured in
6100 Oak Tree Blvd Ste 200, N/A, Independence, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2368-2012Don't want to check this manually?
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