FDAFDA · Food and drugs·Recall number Z-1638-2022
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
Published September 7, 2022 · Recall initiated: July 15, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for the incorrect screw to be included in the package.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aesculap Implant Systems LLC
- Distributor
- GA, TX
- Lot
- GUIDID: 04046964989728 Lot Number: 52758014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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