Reported Feb 7, 2024 · Ongoing
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
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
- REF150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length
- Lot codes and dates
- UDI-DI00810076564005
- LotAP23000143
- Amount recalled
- 6
Where it was sold
Why it was recalled
Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.
This product could cause temporary or reversible health problems — stop using it.
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