Z-2399-2026Class II

Hintermann Series Talar Implant, Left, Size 2 REF 302112

Name: Z-2399-2026 Hintermann Series Talar Implant, Left, Size 2 REF 302112
Creator: DT MedTech, LLC
Published: 2026-03-24
License: https://open.fda.gov/license/

DT MedTech, LLC / initiated 2026-03-24 / Open, Classified / root cause: labeling and UDI

FDA source

DT MedTech, LLC began a recall of Hintermann Series Talar Implant, Left, Size 2 REF 302112 on 2026-03-24. FDA classified it as Class II and gives the reason as "Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2399-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-24
Posted: 2026-06-10
Recalling firm: DT MedTech, LLC
Product: Hintermann Series Talar Implant, Left, Size 2 REF 302112
Product code: NTG Prosthesis, Ankle, Uncemented, Non-Constrained
Reason for recall: Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On March 24, 2026, DT MedTech issued a Urgent Medical Device Recall Notification to affected consignees. DT MedTech requested that the firm take the following actions: 1. Return of all available stock of Hintermann Series Talar Implants (Part/REF number 302112, Lot number AACAA) 2. Please provide confirmation that all available stock of the part detailed below has been returned to Vilex LLC at 4516 S 700 E Suite 100A Salt Lake City, Utah 84107 USA. 3. For any questions or concerns, contact Vilex Quality at [email protected] or 800-521-5002.
Quantity in commerce: 67 units
Distribution: Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.
Product codes and lots: Lot: AACAA/ DI: B095302112

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2399-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2399-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-10

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)