Summary
The FDA issued a Class II for Hintermann Series Talar Implant, Left, Size 2 REF 302112 by DT MedTech, LLC. Reason: Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right im.
Details
Source
Device Recall
External ID
Z-2399-2026
Action Date
2026-06-17
Status
Ongoing
Category
device
Product Description
Hintermann Series Talar Implant, Left, Size 2 REF 302112
Lot/Code Info: Lot: AACAA/ DI: B095302112
Quantity Affected: 67 units
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.
Distribution
Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-24
Company
Mcminnville, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 228 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DT MedTech, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DT MedTech, LLC have FDA actions?
This is the only FDA action we have on record for DT MedTech, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2399-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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