FDA-Device2023-08-30Class II

IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; 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 C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2460-2023

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