FDA-Device2023-08-30Class II
IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B20181973, l) B20182253, m) B20182263; 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
4489 units
Manufactured in
Vancia, Vancia, Rillieux La Pape, N/A, France
Products
IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B20181973, l) B20182253, m) B20182263; intervertebral fusion device - lumbar
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2456-2023Don't want to check this manually?
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