Medicrea International: Medical Device Recall in 2023 - (Recall #: Z-2455-2023)

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 DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; intervertebral fusion device - lumbar

Product Classification:

Class II

Date Initiated: July 12, 2023

Date Posted: August 30, 2023

Recall Number: Z-2455-2023

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: 24 units

Code Information:

a) B16123509, GTIN 03613720196341, Lot Numbers: 20B0490; b) B16123511, GTIN 03613720196358, Lot Numbers: 19G0068; c) B16124009, GTIN 03613720196396, Lot Numbers: 19K0269; d) B16124013, GTIN 03613720196419, Lot Numbers: 19F0715; e) B16124509, GTIN 03613720196440, Lot Numbers: 19F0713; f) B16124511, GTIN 03613720196457, Lot Numbers: 19F0716; g) B16124513, GTIN 03613720196464, Lot Numbers: 19K0270; h) B16164009, GTIN 03613720196495, Lot Numbers: 18F1034; i) B16164013, GTIN 03613720196518, Lot Numbers: 18G0178; j) B16165009, GTIN 03613720196594, Lot Numbers: 18C0626; k) B16165013, GTIN 03613720196617, Lot Numbers: 18C0629;

Distribution Pattern:

US nationwide

Voluntary or Mandated:

Voluntary: Firm initiated