Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Ilizarov Wire Tensioner Recalled by Medicalplastic S.R.L. Due to Medicalplastic s.r.l. is conducting a voluntary field action...

Date: June 17, 2021
Company: Medicalplastic S.R.L.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medicalplastic S.R.L. directly.

Affected Products

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

Quantity: 581 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 1 state: TN

Affected (1 state)Not affected

About Medicalplastic S.R.L.

Medicalplastic S.R.L. has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report