FDAJuly 15, 2022device
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential for the incorrect screw to be included in the package.
What to do
FDA enforcement status: Ongoing
Brands named
aesculap implant systemsaesculapaesculap implant
UPCs
04046964989728
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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