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DT MedTech, LLC: Hintermann Series Talar Implant, Left, Size 2 REF 302112

Medical DevicesSource: FDA (device) · Date: 2026-06-17

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
DT MedTech, LLC
Product
Hintermann Series Talar Implant, Left, Size 2 REF 302112
Reason / hazard
Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.
Recall initiated
2026-03-24
Code info
Lot: AACAA/ DI: B095302112
Product quantity
67 units
Voluntary mandated
Voluntary: Firm initiated
City
Mcminnville
State
TN
Country
United States
Event id
98987
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