FDAClass IISeptember 7, 2022

Aesculap ENNOVATE SET SCREW STERILE-implants are used recall

Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral…

Why was Aesculap ENNOVATE SET SCREW STERILE-implants are used recalled?

Potential for the incorrect screw to be included in the package.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GUIDID: 04046964989728 Lot Number: 52758014

Product
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral…
Recalling firm
Aesculap Implant Systems LLC
Quantity
6 units
Distribution
GA, TX
Recall date
September 7, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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