DT MedTech Hintermann Series Talar Implant recalled for incorrect device in left-labeled packaging
DT MedTech discovered that some Hintermann Series Talar Implant units labeled as left implants actually contained right implants inside the packaging. This mix-up was found through customer complaints. A total of 67 units across five US states and two countries are affected.
From the FDA notice · Read the official notice ↗
What to do
- If you received a Hintermann Series Talar Implant (Left, Size 2, REF 302112) with lot number AACAA, contact DT MedTech immediately to verify the correct implant was supplied.
- Do not implant the device until you have confirmed it matches the packaging label.
- Return the implant to DT MedTech if it does not match the labeled side.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Hintermann Series Talar Implant, Left, Size 2 REF 302112
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 67 units
- Illnesses reported
- None reported
- Manufactured in
- 111 Moffitt St, N/A, Mcminnville, TN, United States
- Classification
- Class II
- Recall number
- Z-2399-2026
In the FDA's words
- Description
- Hintermann Series Talar Implant, Left, Size 2 REF 302112 Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device. Lot: AACAA/ DI: B095302112 Distribution: Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR. Affected quantity: 67 units
- Hazard
- Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.