Recall Z-0402-2019 ยท NTG Prosthesis, Ankle, Uncemented, Non-Constrained
DT MedTech, LLC
DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
| Date | Sep 25, 2018 |
| Status | Terminated |
| Reason | Incorrect package labeling identifying the device |
| Root cause | Packaging process control |
| Action | DT Med Tech LLC initially notified accounts by email notification on 9/25/18 followed by notification letter; The letters explain the process for the identification and return to HealthLink BV (distribution warehouse in The Netherlands) of the products affected (lot AAADP/AAAEM). |
| Quantity | 54 units |
| Distribution | Australia, Ireland, Korea, Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.