DT MedTech, LLC recalls DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bear…
- Recall date
- September 25, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0402-2019
- FDA classification
- Class II
- Brand / firm
- DT MedTech, LLC
- Sold / distributed
- Australia, Ireland, Korea, Germany
Why it was recalled
Incorrect package labeling identifying the device
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
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