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Medicalplastic S.R.L. recalls Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Recalled November 24, 2021 · FDA recall Z-0245-2022 · Medicalplastic S.R.L
Hazard
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. · FDA Class II
Units
581 units
Sold at
Memphis, TN
Description
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.
Product
Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Manufacturer(s)
Medicalplastic S.R.L.
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →