The Recall Desk
HighFDA (Devices)·Z-2399-2026·Announced 2026-06-17

Hintermann left talar implant packaging contained a right-side device

Hintermann Series Talar Implants, Left, Size 2, are being recalled because packaging and labeling for a left implant contained a right implant device. 67 units are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall where the wrong-sided implant is inside correctly labelled packaging, a risk of harm with no injuries reported in the source.

Plain-English summary

The Hintermann Series Talar Implant, Left, Size 2, REF 302112, from DT MedTech, LLC, is being recalled. The action covers 67 units in lot AACAA, DI B095302112.

Through customer complaints, the ankle replacement system was found to contain incorrect devices: left implant packaging and labeling bears a right implant device. The FDA classified the action as Class II.

Distribution was worldwide, including within the United States in California, Arkansas, Arizona and Idaho, and to Peru and South Korea. The implants are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the REF, lot and DI above, quarantine it, and follow the instructions issued by DT MedTech.

The recalled product

Product
Hintermann Series Talar Implant, Left, Size 2 REF 302112
Manufacturer
DT MedTech, LLC
Category
Medical Device — Ankle implant
Hazard
Affected units
67

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: AACAA/ DI: B095302112

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

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