Z-2438-2015Class II

Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products...

Name: Z-2438-2015 Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products...
Creator: Otto Bock Healthcare Product
Published: 2015-08-12
License: https://open.fda.gov/license/

Otto Bock Healthcare Products GmbH / initiated 2015-08-12 / Terminated / root cause: manufacturing process

FDA source

Otto Bock Healthcare Product began a recall of 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... on 2015-08-12. FDA classified it as Class II and gives the reason as "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". 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-2438-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-12
Posted: 2015-08-21
Terminated: 2015-10-28
Recalling firm: Otto Bock Healthcare Products GmbH
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.
Product code: ISW Assembly, Knee/Shank/Ankle/Foot, External
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The consignee was notified via e-mail and telephone on 12 August 2015. The affected product was identified, as well as the reason for the recall. The firm will replace the affected device with a new one. A return authorization and label will be provided for the recalled product to be returned as soon as possible.
Quantity in commerce: 1
Distribution: Distributed to the state OH.
Product codes and lots: Serial Number 201528049, manufactured on 01 July 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2438-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2438-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-21

Product code ISW

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)