Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric… — Class II medical device recall Z-2261-2015
Terminated recall by Otto Bock Healthcare GmbH, reported 2015-08-05, distributed nationwide. Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joints distribut
| Recall number | Z-2261-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Otto Bock Healthcare GmbH, Duderstadt, N/A, Germany |
| Recall initiated | 2015-07-16 |
| Classified | 2015-07-24 |
| Reported by FDA | 2015-08-05 |
| Terminated | 2017-06-21 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
Product
Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.
Reason for recall
Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joints distributed since February 2014 because the locking function may fail under certain conditions which may result in a fall.
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-2261-2015. 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.