CLASS II Device recall · Reported 14 Nov 2018 · FDA Enforcement Report
DT Medical -Hintermann Series H3 Poly Inlay, Size recalled by DT MedTech
DT MedTech is recalling DT Medical -Hintermann Series H3 Poly Inlay, Size 3. The recall was initiated on 25 Sep 2018 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-0402-2019
- FDA event ID
- 81293
- Recalling firm
- DT MedTech, Towson, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Sep 2018
- FDA classified
- 7 Nov 2018
- Reported
- 14 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 25 Sep 2018 | Recall initiated by company | |
| 7 Nov 2018 | Classified by FDA | +43 days |
| 14 Nov 2018 | 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
Incorrect package labeling identifying the 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
DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
Where it was distributed
Australia, Ireland, Korea, Germany
Questions about this recall
Why was it recalled?
Incorrect package labeling identifying the device
Which lots are affected?
Lot: AAADP
Where was it sold?
Australia, Ireland, Korea, Germany
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.
Other products in this recall event
1 other product · FDA event 81293This product is part of a recall event; the main page for the event is DT Medi Tech Hintermann Series Talar Implant Left-size recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | DT Medi Tech Hintermann Series Talar Implant Left-size recalled | DT MedTech | Packaging Defects | MD |
More recalls from DT MedTech
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hintermann Series Talar Implant, Left, Size recalled by DT MedTech | DT MedTech | Packaging Defects | Nationwide |
| Device | CLASS II | DT Medi Tech Hintermann Series Talar Implant Left-size recalled | DT MedTech | Packaging Defects | MD |
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