Medicrea International: Medical Device Recall in 2023 - (Recall #: Z-2453-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 12, 2023

Date Posted: August 30, 2023

Recall Number: Z-2453-2023

Event ID: 92738

Reason for Recall:

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

Status: Ongoing

Product Quantity: 11 units

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

Voluntary or Mandated:

Voluntary: Firm initiated