# FDA recall Z-1472-2020

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

## 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  B36007535  B36007540  B36007545  B36007550  B36007555  B36007560  B36008535  B36008540  B36008545  B36008550  B36008555  B36008560  B36009535  B36009540  B36009545  B36009550  B36009555  B36009560    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-1472-2020
- **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-1472-2020

## Citation

> AI Analytics. FDA recall Z-1472-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1472-2020. Source: US FDA. Licensed CC0.

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