XTANT Medical recalls X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
Read the official notice →- Date
- 2022-02-09
- Country
- United States
- Brand
- XTANT Medical
- Product
- X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
- Classification
- Class II
- Units
- U.S.: CA, MI, NV, and TX O.U.S.: Portugal
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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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