medical Class II Updated 2023-08-30

Medicrea International recalls IMPIX ALIF, REF numbers: a) B15111209, b) B15111212,

Recalled Product

IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar


Hazard / Issue

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: a) B15111209, GTIN 03613720193395, Lot Numbers: 19C0772; b) B15111212, GTIN 03613720193401, Lot Numbers: 19C0775, 19G0070; c) B15111409, GTIN 03613720193425, Lot Numbers: 19E0353; d) B15111412, GTIN 03613720193432, Lot Numbers: 19C0788
View official government recall

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