The Recall Desk

FDA (Devices) recall action 84928

Medicrea International recalled 2 products on 2020-03-18

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-03-18
Critical
0
Units
7,058

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2020-03-18

    Medicrea Iliac Screws Recalled Due to Incorrect Component Orientation

    Medicrea International is recalling 3,529 Iliac Screws because an internal component was assembled incorrectly, which may cause the tulip head to disengage from the shank.

    Product
    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 confor
    Category
    Distribution
    6 states
  • HighFDA (Devices)··2020-03-18

    Medicrea Recalls Pedicle Screws Due to Incorrect Component Orientation

    Medicrea International is recalling 3,529 pedicle screws because an internal component was assembled incorrectly, which may cause the tulip head to disengage from the screw shank.

    Product
    Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B36005540 B36005545 B36005550 B36005555 B36005560 B36006530 B36006535 B36006540 B36006545 B36006550 B36006555 B36006560 B
    Category
    Distribution
    6 states