Reported Sep 7, 2022 · Ongoing
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the…
Aesculap Implant Systems LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aesculap Implant Systems LLC · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217
Is this the product you have?
- Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine
- Article Number52758014
- Lot codes and dates
- GUIDID04046964989728
- Lot Number52758014
- Amount recalled
- 6 units
Where it was sold
Why it was recalled
Potential for the incorrect screw to be included in the package.
This product could cause temporary or reversible health problems — stop using it.
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