MEDICALPLASTIC
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (2)
Devices registered here (4)
- Software For Diagnosis/TreatmentProduct code OSN (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3030
- Pin, Fixation, ThreadedProduct code JDW (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3040
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentProduct code KTT (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3030
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeProduct code LXT (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3030
Recalls & enforcement
- Class IIOngoing2021-06-17Medicalplastic 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…
FDA inspections (2)
- VAI2026-03-19Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
- NAI2018-12-17No Action Indicated · Compliance: Devices
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “MEDICALPLASTIC (FEI 3002807648) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002807648-medicalplastic/
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