Recall Z-1473-2020— Medicrea International

Name: FDA recall Z-1473-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-28

Class II · Terminated

Class II FDA medical device recall by Medicrea International, initiated 2020-01-28, terminated 2023-03-17. It names one FDA 510(k) clearance: K190376. 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 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.. Reason: 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..

Recalling firm: Medicrea International
Classification: Class II
Status: Terminated
Initiated: 2020-01-28
Terminated: 2023-03-17
Firm location: Rillieux La Pape, France

510(k) clearances named in this recall

1 on FDA's record

K190376 — PASS LP Spinal SystemMedicrea International SA·cleared 2019-05-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.