Recall Z-2399-2026 ยท NTG Prosthesis, Ankle, Uncemented, Non-Constrained
DT MedTech, LLC
Hintermann Series Talar Implant, Left, Size 2 REF 302112
| Date | Jun 10, 2026 (initiated Mar 24, 2026) |
| Status | Open, Classified |
| Reason | Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device. |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 67 units |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.