Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-0245-2022 · Posted None

Recalling FirmMedicalplastic S.R.L.
Recall StatusOpen, Classified
Product CodeKTT
Date Initiated2021-06-17
Product Quantity581 units

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.

Firm Action

The firm notified its sole consignee of the issue and its intent to recall by email on 06/17/2021. The recalled washers will be replaced.

Root Cause

Process control

Distribution Pattern

Memphis, TN

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093047SMITH & NEPHEW CIRCULAR FIXATION SYSTEMSmith & Nephew, Inc. · 2010-09-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑