Dt Medtech, Llc: Prosthesis, Ankle, Uncemented, Non-constrained
Recall Summary DT MedTech is recalling certain Hintermann Series Talar Implant ankle replacement devices (Left, Size 2, REF 302112) because the packaging and labeling indicate a left implant when the device inside is actually a right implant. This mislabeling could result in surgeons implanting the wrong side during ankle replacement surgery. The affected devices were distributed nationwide in the US and in Peru and South Korea.
- Recalling firm
- DT MedTech, LLC
- Product
- Hintermann Series Talar Implant, Left, Size 2 REF 302112
- Reason
- 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 III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-24
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/b847da4d-0d85-4fe7-9d7c-0ff0a013e8da