Z-0608-2016Class II

Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting...

Name: Z-0608-2016 Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting...
Creator: Otto Bock Healthcare GmbH
Published: 2016-01-04
License: https://open.fda.gov/license/

Otto Bock Healthcare LP / initiated 2016-01-04 / Terminated / root cause: manufacturing process

FDA source

Otto Bock Healthcare GmbH began a recall of Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb on 2016-01-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0608-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-04
Posted: 2016-02-01
Terminated: 2016-05-02
Recalling firm: Otto Bock Healthcare LP
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.
Product code: ISY Joint, Knee, External Limb Component
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Starting Jan 4 2016, In coordination with the Manufacturer, the US Agent will notify customers via telephone call of the correction on behalf of the Manufacturer. The customers will be requested to return the affected devices back to the service center for correction. The devices will be returned to the customer following correction.
Quantity in commerce: 40 units
Distribution: Nationwide Distribution.
Product codes and lots: All serviced between 27 April 2015 and 17 November 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0608-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0608-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07

Product code ISY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)