Ottobock Modular Polycentric EBS Knee Joint 3R60 — Class II medical device recall Z-0608-2016
Terminated recall by Otto Bock Healthcare GmbH, reported 2016-01-13, distributed nationwide. Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced between 27 April
| Recall number | Z-0608-2016 |
|---|---|
| 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 | 2016-01-04 |
| Classified | 2016-01-07 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2016-05-02 |
| Distributed | Nationwide (US) |
| Quantity | 40 units |
Product
Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.
Reason for recall
Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced between 27 April 2015 and 17 November 2015 due to a service error where the wrong Loctite was used during repair.
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-0608-2016. 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.