Medtronic Sofamor Danek USA Inc recalls Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
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…
Read the official notice →- Date
- 2023-11-01
- Country
- United States
- Brand
- Medtronic Sofamor Danek
- Product
- Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
- Classification
- Class II
- Units
- US, Colombia, S. Korea, New Zealand, India, Taiwan
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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