Z-0402-2019 Class II Terminated

Recalled by DT MedTech, LLC — Towson, MD

Recall Details

Product Type
Devices
Report Date
November 14, 2018
Initiation Date
September 25, 2018
Termination Date
December 5, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
54 units

Product Description

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 Pattern

Australia, Ireland, Korea, Germany

Code Information

Lot: AAADP