Medicrea International: Medical Device Recall in 2020 - (Recall #: Z-1473-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580 B36027590 B36028500 B36028570 B36028580 B36028590 B36029500 B36029570 B36029580 B36029590 Screws manufactured in titanium alloy Ti-6Al-4V LI conforming to ISO5832-3 and ASTM. F136 specifications. These screws are part of an internal fixation system composed of hooks, rods, plates, cross links, connection and locking devices.

Product Classification:

Class II

Date Initiated: January 28, 2020

Date Posted: March 18, 2020

Recall Number: Z-1473-2020

Event ID: 84928

Reason for Recall:

An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.

Status: Terminated

Product Quantity: 3529

Code Information:

Lots 19D0683 19D0684 19D0685 19D0686 19D0369 19H0470 19D0370 19H0473 19D0371 19G1071 19L0501 19D0372 19G1073 19D0570 19G1075 19J0445 19D0571 19G1076 19J0867 19D0572 19G0521 19J0868 19L0526 19L0502 19L0525 19D0573 19G0522 19J0869 19D0574 19G1077 19L0503 19D0575 19H0474 19D0576 19G0523 19G1078 19D0577 19G1079 19H0475

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of CO, FL, GA, LA, OH, and RI. International distribution to Greece and Portugal.

Voluntary or Mandated:

Voluntary: Firm initiated