Reported Feb 9, 2022 · Terminated
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
XTANT Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: XTANT Medical · 664 Cruiser Ln · Belgrade, MT · 59714-9719
Is this the product you have?
X060-02708mm Titanium InsertAxle Interspinous Fusion System
- Lot codes and dates
X060-02708mm Titanium Insert
- Axle System UDI (Primary DI Number)M697X06002701/$$7058963W
- Lot Number058963
- Amount recalled
- 24 devices
Where it was sold
Why it was recalled
The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
This product could cause temporary or reversible health problems — stop using it.
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