Medicalplastic S.R.L. recalls Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434

Recall date

June 17, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0245-2022

FDA classification

Class II

Brand / firm

Medicalplastic S.R.L.

Sold / distributed

Memphis, TN

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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