CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report
Hintermann Series Talar Implant, Left, Size recalled by DT MedTech
DT MedTech is recalling Hintermann Series Talar Implant, Left, Size 2, distributed nationwide in the US. The recall was initiated on 24 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2399-2026
- FDA event ID
- 98987
- Recalling firm
- DT MedTech, Mcminnville, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Mar 2026
- FDA classified
- 10 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 24 Mar 2026 | Recall initiated by company | |
| 10 Jun 2026 | Classified by FDA | +78 days |
| 17 Jun 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Hintermann Series Talar Implant, Left, Size 2 REF 302112
Where it was distributed
Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.
Questions about this recall
Why was it recalled?
Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
Which lots are affected?
Lot: AACAA/ DI: B095302112
Where was it sold?
Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from DT MedTech
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DT Medical -Hintermann Series H3 Poly Inlay, Size recalled by DT MedTech | DT MedTech | Packaging Defects | MD |
| Device | CLASS II | DT Medi Tech Hintermann Series Talar Implant Left-size recalled | DT MedTech | Packaging Defects | MD |
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