Aesculap Implant Systems LLC 2022-09-07 Health serious FDA
Health · FDA · Recall #FDA-Z-1638-2022
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and… Recall
Issued September 7, 2022 · Aesculap Implant Systems LLC
In September 2022, Aesculap Implant Systems LLC recalled the Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Potential for the incorrect screw to be included in the package.
What you should do
- 1 Stop using Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Aesculap Implant Systems LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Aesculap Implant Systems LLC
- Category
- Health
- Recall date
- September 7, 2022
- Units affected
- Not reported
- Sold at
- GA, TX
- Recall number
- FDA-Z-1638-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Aesculap Implant Systems LLC has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.