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Medicrea International recalls IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B159
Recalled August 30, 2023 · FDA recall Z-2457-2023 · 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. · FDA Class II
Units
730 units
Sold at
US nationwide
Description
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Product
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
Manufacturer(s)
Medicrea International
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →