RegWardenFDA facility compliance records
Facility

DT MEDTECH LLC

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

Activity by year

FDA actions on record by year2017: 1 inspections; 2018: 1 recalls; 2026: 1 recalls1201712018201920202021202220232024202512026
  • Recalls (2)
  • Inspections (1)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2026-03-24
    Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
  • Class IITerminated2018-09-25
    Incorrect package labeling identifying the device

FDA inspections (1)

  • VAI2017-10-24
    Voluntary 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. “DT MEDTECH LLC (FEI 3012104767) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012104767-dt-medtech-llc/

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