FDA-Device2023-08-30Class II
IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; 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
11 units
Manufactured in
Vancia, Vancia, Rillieux La Pape, N/A, France
Products
IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2453-2023Don't want to check this manually?
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