Medicrea International: Medical Device Recall in 2023 - (Recall #: Z-2461-2023)

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 S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical

Product Classification:

Class II

Date Initiated: July 12, 2023

Date Posted: August 30, 2023

Recall Number: Z-2461-2023

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: 0 (US)

Code Information:

a) B15328071S, GTIN 03613720195535, Lot Numbers: 19I0696, 20A0759; b) B15328073S, GTIN 03613720195573, Lot Numbers: 20B0747; c) B15328074S, GTIN 03613720195597, Lot Numbers: 19I0698; d) B15334072S, GTIN 03613720195832, Lot Numbers: 19I0557, 20F0185; e) B15334073S, GTIN 03613720195856, Lot Numbers: 19J0947; f) B15334074S, GTIN 03613720195870, Lot Numbers: 19E0502, 19J0091, 20F0184

Distribution Pattern:

US nationwide

Voluntary or Mandated:

Voluntary: Firm initiated