RegWardenFDA facility compliance records
Facility

MEDICALPLASTIC

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2018: 1 inspections; 2021: 1 recalls; 2026: 1 inspections2017120182019202012021202220232024202512026
  • Recalls (1)
  • Inspections (2)

Devices registered here (4)

  • Software For Diagnosis/Treatment
    Product code OSN (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3030
  • Pin, Fixation, Threaded
    Product code JDW (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3040
  • Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
    Product code KTT (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3030
  • Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
    Product code LXT (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3030

Recalls & enforcement

  • Class IIOngoing2021-06-17
    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…

FDA inspections (2)

  • VAI2026-03-19
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2018-12-17
    No 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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