FDA recall Z-0245-2022

Product

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

Reason for recall

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.

Distribution

Memphis, TN

Key facts

Status

Ongoing

Initiation date

2021-06-17

Report date

2021-11-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Milan, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0245-2022