FDA recall Z-0402-2019

Product

DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.

Reason for recall

Incorrect package labeling identifying the device

Distribution

Australia, Ireland, Korea, Germany

Key facts

Status

Terminated

Initiation date

2018-09-25

Report date

2018-11-14

Termination date

2019-12-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Towson, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0402-2019