Device product
Hintermann Series Talar Implant, Left, Size 2 REF 302112
Z-2399-2026
Product summary
- Firm
- DT MedTech, LLC
- Event
- Event 98987
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 67 units
- Official record key
device-enforcement:Z-2399-2026
Official wording
Reason: Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
Code information: Lot: AACAA/ DI: B095302112
Distribution pattern: Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.
Derived failure modes
-
Unknown
Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.