FDA-Device2021-11-24Class II
Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
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.
Sold states
Memphis, TN
Affected count
581 units
Manufactured in
Via Saverio Mercadante 15, N/A, Milan, N/A, Italy
Products
Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0245-2022Don't want to check this manually?
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