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Recall

Class II — DT MedTech, LLC

Recalling firmDT MedTech LLC
Registered facilityDT MEDTECH LLC (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonThrough customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
ProductHintermann Series Talar Implant, Left, Size 2 REF 302112
Quantity67 units
DistributionWorldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.
Initiated2026-03-24
Classified2026-06-10
Recall numberZ-2399-2026
InitiationVoluntary: 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 — DT MedTech, LLC (Z-2399-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98987/

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