Reported Oct 23, 2024 · Ongoing
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
XTANT Medical Holdings, Inc.
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 Holdings, Inc · 664 Cruiser Ln · Belgrade, MT · 59714-9719
Is this the product you have?
- Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm
- REF150100-65045
- Lot codes and dates
- UDI-DI00810076563190
- LotDNI
- Amount recalled
- 330
Where it was sold
Why it was recalled
Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.
This product could cause temporary or reversible health problems — stop using it.
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