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Lucero Medical LLC recalls Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for
Recalled September 19, 2012 · FDA recall Z-2368-2012 · Lucero Medical
Hazard
The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation. · FDA Class II
Units
169
Sold at
US Nationwide Distribution
Description
The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation.
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.
Manufacturer(s)
Lucero Medical LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →