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Recall Observatory FDA recall evidence

Device product

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

Z-2453-2023

July 12, 2023

Class II

Product summary

Firm
Medicrea International
Event
Event 92738
Status
Ongoing
Classification
Class II
Quantity
11 units
Official record key
device-enforcement:Z-2453-2023

Official wording

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

Code information: 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

Distribution pattern: US nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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