FDA-Device2023-08-30Class II
IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar
Medicrea International
Hazard
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Sold states
US nationwide
Affected count
5 units
Manufactured in
Vancia, Vancia, Rillieux La Pape, N/A, France
Products
IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2454-2023Don't want to check this manually?
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