← FDA ENFORCEMENT
Z-2399-2026Class II

DT MedTech, LLC

Recalling firm
DT MedTech, LLC
Product type
Device
Status
Ongoing
Report date
2026-06-17
Distribution
Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.
Firm state
TN
Product quantity
67 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.

Product description

Hintermann Series Talar Implant, Left, Size 2 REF 302112

Code / lot info

Lot: AACAA/ DI: B095302112

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.