FDA recall, , Moderate risk
DT MedTech Hintermann Series Talar Implant
The Hintermann Series Talar Implant, Left, Size 2 has incorrect packaging labeling a right implant device.
Summary by Recall Canary from the FDA notice
What happened
DT MedTech, LLC, of Mcminnville, Tennessee, recalled the Hintermann Series Talar Implant, Left, Size 2 REF 302112 after customer complaints found the ankle replacement system contained incorrect devices: left implant packaging and labeling bears a right implant device. The recall began March 24, 2026, and was added to the FDA's Enforcement Report on June 10, 2026.
The recalled product was distributed worldwide, with US nationwide distribution in the states of Arkansas, Arizona, California and Idaho, and in the countries of Peru and Korea. The recall involved 67 units.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its lot code matches.
Hintermann Series Talar Implant, Left, Size 2 REF 302112
- Lot code
- B095302112
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of California, Arkansas, Arizona, Idaho and the countries of PER, KOR.
- Company
- DT MedTech, LLCMcminnville, Tennessee
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98987
- Recall number
- Z-2399-2026
- Quantity recalled
- 67 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
