The Recall Desk
HighFDA (Devices)·Z-1322-2015·Announced 2015-04-01

Ossur Recalls Rheo Knee Bionic Prosthetic Due to Assembly Defects

Ossur is recalling two Rheo Knee bionic prosthetic units because they were released for distribution without completing the full assembly process.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device released without completing the assembly process, which poses a risk of harm to the user. As no specific injuries or illnesses have been reported in the source text, the severity is classified as High.

Plain-English summary

Ossur H / F is recalling two units of the Rheo Knee bionic prosthetic. The recall was initiated after an internal audit of the service line revealed that these specific devices were released for distribution without fully going through the required assembly process.

The affected units are identified by serial numbers 323056 and 321498. The product is a bionic prosthetic designed for lower extremity amputations that uses artificial intelligence to adapt to the user's walking style and environment. The recall involves a total of 4,715 units, with only the two specific serial numbers listed as affected.

Distribution for this product is worldwide, with specific US distribution noted in Tennessee and distribution in Austria. Consumers who possess these specific serial numbers should contact the manufacturer for instructions on how to proceed.

The recalled product

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,
Manufacturer
Ossur H / F
Category
Medical Device — Prosthetic Limb
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Rheo 2 Item Number: RKN120007 Serial #s affected: 323056 321498

Distribution

Distributed in 1 state:

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