FDAJune 17, 2021device
Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
medicalplastic s r lmedicalplastic
UPCs
08033201842072
Recall history
No related federal recalls on record for this brand yet.
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