FDA-Device2023-08-30Class II
IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; 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
730 units
Manufactured in
Vancia, Vancia, Rillieux La Pape, N/A, France
Products
IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbar
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2457-2023Don't want to check this manually?
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