Medtronic Sofamor Danek USA Inc 2023-11-01 Health serious FDA
Health · FDA · Recall #FDA-Z-0162-2024
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix Recall
Issued November 1, 2023 · Medtronic Sofamor Danek USA Inc
In November 2023, Medtronic Sofamor Danek USA Inc recalled the Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
What you should do
- 1 Stop using Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix 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
- November 1, 2023
- Units affected
- Not reported
- Sold at
- US, Colombia, S. Korea, New Zealand, India, Taiwan
- Recall number
- FDA-Z-0162-2024
- 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.