Home / Recalls / DT MedTech, LLC / Z-0403-2019

Z-0403-2019 Class II Terminated

Recalled by DT MedTech, LLC — Towson, MD

FDA device recall Z-0403-2019 was initiated by DT MedTech, LLC on September 25, 2018 and is designated Class II. Reason for recall: Incorrect package labeling identifying the device The recall status is terminated (terminated December 5, 2019). Affected quantity: 1.

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: 1

Product Description

DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 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: AAAEM