DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0402-2019.
Incorrect package labeling identifying the device
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0402-2019.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Dt Medtech, Llc or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0402-2019.
DT MedTech, LLC
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Dt Medtech, Llc Recall FAQ
Dt Medtech, Llc is the subject of a medical implants safety report: DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.. The notice was published on September 25, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 54 units are potentially affected.