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[Recalled] Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014 — Potential for the incorrect screw to be include

recall fda device united-states

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

ProductAesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
Brand / manufacturerAesculap Implant Systems LLC
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1638-2022
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date15 July 2022
EAN / barcode04046964989728

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Potential for the incorrect screw to be included in the package.

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 →

Related recalls from Aesculap Implant Systems LLC

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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