FDA-Device2023-08-30Class II
IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
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
0 (US)
Manufactured in
Vancia, Vancia, Rillieux La Pape, N/A, France
Products
IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2461-2023Don't want to check this manually?
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