Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2 — Class II medical device recall Z-2438-2015
Terminated recall by Otto Bock Healthcare Product, reported 2015-09-02. Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to issues with the
| Recall number | Z-2438-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Otto Bock Healthcare Product, Wien, N/A, Austria |
| Recall initiated | 2015-08-12 |
| Classified | 2015-08-21 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2015-10-28 |
| Quantity | 1 |
| Reason classes | device malfunction |
| Serial numbers | 201528049 |
| Model numbers | 3B5-2 |
Product
Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings.
Reason for recall
Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to issues with the resistance-control of the hydraulics, which may fail under conditions.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2438-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.