FDA DevicesClass II
Hintermann Series Talar Implant, Left, Size 2 REF 302112
Published: June 17, 2026Recall ID: Z-2399-2026Category: devicesCountry: US
Reason for Recall / Hazard
Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
Product Description & Identification
Hintermann Series Talar Implant, Left, Size 2 REF 302112
Affected Products
Hintermann Series Talar Implant, Left, Size 2 REF 302112
Additional Source Details
| Field | Value |
|---|---|
| City | Mcminnville |
| State | TN |
| Event id | 98987 |
| Address 1 | 111 Moffitt St |
| Address 2 | N/A |
| Code info | Lot: AACAA/ DI: B095302112 |
| Postal code | 37110-2235 |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 67 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260324 |
| Initial firm notification | |
| Center classification date | 20260610 |
Overview
- Recalling FirmDT MedTech, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.