Recall Z-2399-2026
DT MedTech, LLC · initiated March 24, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Hintermann Series Talar Implant, Left, Size 2 REF 302112
Codes / lots: Lot: AACAA/ DI: B095302112
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.
FDA-determined cause: Labeling Change Control
Action taken
On March 24, 2026, DT MedTech issued a Urgent Medical Device Recall Notification to affected consignees. DT MedTech requested that the firm take the following actions: 1. Return of all available stock of Hintermann Series Talar Implants (Part/REF number 302112, Lot number AACAA) 2. Please provide confirmation that all available stock of the part detailed below has been returned to Vilex LLC at 4516 S 700 E Suite 100A Salt Lake City, Utah 84107 USA. 3. For any questions or concerns, contact Vilex Quality at quality@vilex.com or 800-521-5002.
Details
- Recall number
- Z-2399-2026
- Initiated
- March 24, 2026
- Posted by FDA
- June 10, 2026
- Product code
- NTG – Prosthesis, Ankle, Uncemented, Non-Constrained
- Quantity
- 67 units
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.
- Recalling firm
- DT MedTech, LLC, Mcminnville, TN