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Terminated

DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.

FDA Recall Z-0403-2019 · Posted None

Recalling FirmDT MedTech, LLC
Recall StatusTerminated
Product CodeNTG
Date Initiated2018-09-25
Date Terminated2019-12-05
Product Quantity1

Reason for Recall

Incorrect package labeling identifying the device

Firm Action

DT Med Tech LLC initially notified accounts by email notification on 9/25/18 followed by notification letter; The letters explain the process for the identification and return to HealthLink BV (distribution warehouse in The Netherlands) of the products affected (lot AAADP/AAAEM).

Root Cause

Packaging process control

Distribution Pattern

Australia, Ireland, Korea, Germany

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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