DT MedTech Recalls Ankle Joint Inlays Due to Incorrect Package Labeling
DT MedTech is recalling 54 units of Hintermann Series H3 Poly Inlays because the package labeling incorrectly identifies the device.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 involves a minor labeling error with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
DT MedTech, LLC is recalling 54 units of the DT Medical Hintermann Series H3 Poly Inlay, Size 3 5mm (Part Number: 300305). These components are prostheses designed for a mobile bearing ankle joint. The recall is being conducted because the package labeling incorrectly identifies the device.
The affected units are from Lot AAADP. The source text indicates that these devices were distributed to Australia, Ireland, Korea, and Germany.
Healthcare providers and patients should stop using the affected devices and contact DT MedTech, LLC for further instructions on how to return or replace the product.
The recalled product
- Product
- DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
- Manufacturer
- DT MedTech, LLC
- Hazard
- Affected units
- 54
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: AAADP
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 →Related recalls
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