The Recall Desk
ModerateFDA (Devices)·Z-0403-2019·Announced 2018-11-14

DT MedTech Recalls Ankle Implant Due to Incorrect Package Labeling

DT MedTech is recalling specific talar implants for ankle joints because the package labels incorrectly identify the device.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies the issue as 'Incorrect package labeling' without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving labeling errors.

Plain-English summary

DT MedTech, LLC is recalling the DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 (Part Number: 302114). These components are prostheses designed for a mobile bearing ankle joint. The recall is being conducted because of incorrect package labeling that identifies the device.

The affected units are identified by Lot AAAEM. According to the structured product information, these devices were distributed in Australia, Ireland, Korea, and Germany. The source text does not specify the total number of units recalled or the specific dates of distribution.

Healthcare providers and patients who have received or used these specific implants should contact DT MedTech, LLC for further instructions on how to proceed. The recall is limited to the specific lot and part number identified in the notice.

The recalled product

Product
DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.
Manufacturer
DT MedTech, LLC
Affected units
1

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: AAAEM

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by DT MedTech, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · DT MedTech, LLC

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