Class II — Medicalplastic S.R.L.
| Recalling firm | MEDICALPLASTIC |
|---|---|
| Registered facility | MEDICALPLASTIC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434 |
| Quantity | 581 units |
| Distribution | Memphis, TN |
| Initiated | 2021-06-17 |
| Classified | 2021-11-17 |
| Recall number | Z-0245-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medicalplastic S.R.L. (Z-0245-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88785/
Alerts for MEDICALPLASTIC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.