Z-0403-2019Class II

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

Name: Z-0403-2019 DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a...
Creator: DT MedTech, LLC
Published: 2018-09-25
License: https://open.fda.gov/license/

DT MedTech, LLC / initiated 2018-09-25 / Terminated / root cause: packaging

FDA source

DT MedTech, LLC began a recall of DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint on 2018-09-25. FDA classified it as Class II and gives the reason as "Incorrect package labeling identifying the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0403-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-25
Posted: 2018-11-07
Terminated: 2019-12-05
Recalling firm: DT MedTech, LLC
Product: DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.
Product code: NTG Prosthesis, Ankle, Uncemented, Non-Constrained
Reason for recall: Incorrect package labeling identifying the device
Root cause tag: packaging
FDA root cause: Packaging process control
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).
Quantity in commerce: 1
Distribution: Australia, Ireland, Korea, Germany
Product codes and lots: Lot: AAAEM

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0403-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0402-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-07
Z-0403-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-07

Product code NTG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)