# FDA recall Z-0245-2022

> **Medicalplastic S.R.L.** · Class II · device recall initiated 2021-06-17.

## Product

Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434

## Reason for recall

Medicalplastic s.r.l. is conducting a voluntary field action to remove a group of Ilizarov Wire Tensioners due to a manufacturing error.  An internal washer of the Ilizarov Wire Tensioner has been made in a wrong plastic material that could wear and break during the sterilization process in autoclave. Consequently this could cause malfunctioning of the tensioner.

## Distribution

Memphis, TN

## Key facts

- **Recall number:** Z-0245-2022
- **Recalling firm:** Medicalplastic S.R.L.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-06-17
- **Report date:** 2021-11-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Milan, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0245-2022

## Citation

> AI Analytics. FDA recall Z-0245-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0245-2022. Source: US FDA. Licensed CC0.

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