DT MEDTECH LLC
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
- Inspections (1)
Devices registered here (1)
- Starter, Bone ScrewProduct code HWD (opens in a new tab) · Class I · Orthopedic · 21 CFR 888.4540
Recalls & enforcement
- Class IIOngoing2026-03-24Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
- Class IITerminated2018-09-25Incorrect package labeling identifying the device
FDA inspections (1)
- VAI2017-10-24Voluntary 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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