Medtronic Sofamor Danek USA Inc 2023-04-26 Health serious FDA
Health · FDA · Recall #FDA-Z-1409-2023
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm,… Recall
Issued April 26, 2023 · Medtronic Sofamor Danek USA Inc
In April 2023, Medtronic Sofamor Danek USA Inc recalled the INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
What you should do
- 1 Stop using INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Medtronic Sofamor Danek USA Inc 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
- Medtronic Sofamor Danek USA Inc
- Category
- Health
- Recall date
- April 26, 2023
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall number
- FDA-Z-1409-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Medtronic Sofamor Danek USA Inc has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.