FDA-Device2018-11-14Class II

DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 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
1
Manufactured in
110 West Rd Ste 227, Towson, MD, United States
Products
DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0403-2019

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