FDA-Device2026-06-17Class IIMISBRANDING
DT MedTech Hintermann Series Talar Implant recalled for incorrect device in left-labeled packaging
LABEL MIX UPNationwide distribution
DT MedTech Hintermann ankle implant recalled for wrong device packaged
DT MedTech discovered that some Hintermann Series Talar Implant units labeled as left implants actually contained right implants inside the packaging. This mix-up was found through customer complaints. A total of 67 units across five US states and two countries are affected.
- If you received a Hintermann Series Talar Implant (Left, Size 2, REF 302112) with lot number AACAA, contact DT MedTech immediately to verify the correct implant was supplied.
- Do not implant the device until you have confirmed it matches the packaging label.
- Return the implant to DT MedTech if it does not match the labeled side.
Hazard
Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
Sold states
Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.
Affected count
67 units
Manufactured in
111 Moffitt St, N/A, Mcminnville, TN, United States
Products
Hintermann Series Talar Implant, Left, Size 2 REF 302112
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2399-2026Don't want to check this manually?
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