Z-1322-2015Class II

The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO...

Name: Z-1322-2015 The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO...
Creator: Ossur H / F
Published: 2015-02-26
License: https://open.fda.gov/license/

Ossur Iceland ehf. / initiated 2015-02-26 / Terminated / root cause: manufacturing process

FDA source

Ossur H / F began a recall of The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously... on 2015-02-26. FDA classified it as Class II and gives the reason as "The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process". 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-1322-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-26
Posted: 2015-03-25
Terminated: 2015-11-20
Recalling firm: Ossur Iceland ehf.
Product: The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.
Product code: ISW Assembly, Knee/Shank/Ankle/Foot, External
Reason for recall: The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Ossur, notified their customers of the Recall Notice via phone on February 26, 2015. The firm informed the customers about the recalled product, the problem and actions to be taken. The customers were instructed to send the unit in for service so the Acceptance testing can be performed for the unit in accordance to their process. If you have any questions, please contact Regulatory Affairs & Quality Assurance specialist at 949-382-3741 or email: [email protected].
Quantity in commerce: 4715 units (2 units affected)
Distribution: Worldwide distribution: US distribution in TN and country of: Austria.
Product codes and lots: Rheo 2 Item Number: RKN120007 Serial #s affected: 323056 321498

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1322-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1322-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-25

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)