Recall Z-0245-2022— Medicalplastic S.R.L.

Name: FDA recall Z-0245-2022
Creator: U.S. Food and Drug Administration
Published: 2021-06-17

Class II · Ongoing

Class II FDA medical device recall by Medicalplastic S.R.L., initiated 2021-06-17. It names one FDA 510(k) clearance: K093047. Product: Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434. Reason: 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..

Recalling firm: Medicalplastic S.R.L.
Classification: Class II
Status: Ongoing
Initiated: 2021-06-17
Firm location: Milan, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K093047 — SMITH & NEPHEW CIRCULAR FIXATION SYSTEMSmith & Nephew, Inc.·cleared 2010-09-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.