FDA-Device2018-11-14Class II
DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
DT MedTech, LLC
Hazard
Incorrect package labeling identifying the device
Sold states
Australia, Ireland, Korea, Germany
Affected count
54 units
Manufactured in
110 West Rd Ste 227, Towson, MD, United States
Products
DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0402-2019Don't want to check this manually?
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