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Aesculap Implant Systems LLC Recall 90678

Description: Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014

Aesculap Implant Systems LLC Recall 90678 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1638-2022
Event ID90678
Event DescriptionAesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
Product TypeDevices
DistributionGA, TX
Quantity6 units
Recall ReasonPotential for the incorrect screw to be included in the package.
Device Classification20220907
Device Code InfoGUIDID: 04046964989728 Lot Number: 52758014
Center Classification Date20220826
Recall Initiation Date20220715
Recalling FirmAesculap Implant Systems LLC
Initial Notification Letter
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