# FDA recall Z-1473-2020

> **Medicrea International** · Class II · device recall initiated 2020-01-28.

## 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 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1473-2020
- **Recalling firm:** Medicrea International
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-28
- **Report date:** 2020-03-18
- **Termination date:** 2023-03-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rillieux La Pape, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1473-2020

## Citation

> AI Analytics. FDA recall Z-1473-2020. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1473-2020. Source: US FDA. Licensed CC0.

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