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[Recalled] 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

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductEnduramesh 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
Brand / manufacturerLucero Medical LLC
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2368-2012
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date15 July 2012
EAN / barcode20121901

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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