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TRUVACE RECORD VERSION
record: TRV-2026-0042
version: 2
kind: revised
reason: Model backfill: grounded claim, summary, sector, and trace validation
timestamp: 2026-07-13T00:40:33.719152Z
status: published
lens: p_space
sector: health
headline: Ossur H F Grjothals 5 Reykjavik Iceland recalls an AI-enabled medical device
dek: 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 t… Recall reason: 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.
gain_title: (none)
problem_title: Lower-extremity amputees received Rheo Knee AI prosthetics that had been released without completing the full assembly process, triggering a recall for acceptance testing
trace_subject: (none)
gain_reading: (none)
problem_reading: Lower-extremity amputees received Rheo Knee AI prosthetics that had been released without completing the full assembly process, triggering a recall for acceptance testing
quick_read: Ossur recalled its Rheo Knee bionic prosthetic after an internal audit found units were released for distribution without fully going through the assembly process. The device is described as using Artificial Intelligence to adapt to walking style and environment for lower extremity amputations, and customers were told on February 26, 2015 to return units for acceptance testing.

The recall matters because an AI-controlled knee that has not completed assembly and testing could fail to respond correctly to speed, load and terrain changes, creating fall or injury risk for amputees. It remains uncertain how many units were distributed, whether any adverse events occurred, and what the acceptance testing results showed.
limitation: Article does not report number of units affected, injuries, or whether acceptance testing found failures
tag: Evidence-backed problem
key_points: Device is identified as RHEO KNEE bionic prosthetic for lower extremity amputations | Firm Ossur H F Grjothals 5 Reykjavik Iceland notified customers via phone on February 26, 2015 | Customers were instructed to send the unit in for service so the Acceptance testing can be performed
rundown: Ossur recalled its Rheo Knee bionic prosthetic after an internal audit found units were released for distribution without fully going through the assembly process. The device is described as using Artificial Intelligence to adapt to walking style and environment for lower extremity amputations, and customers were told on February 26, 2015 to return units for acceptance testing.

The recall matters because an AI-controlled knee that has not completed assembly and testing could fail to respond correctly to speed, load and terrain changes, creating fall or injury risk for amputees. It remains uncertain how many units were distributed, whether any adverse events occurred, and what the acceptance testing results showed.
sources:
- government | FDA medical-device recall 134496 | https://api.fda.gov/device/recall.json?search=cfres_id%3A%22134496%22&sort=event_date_created%3Adesc&limit=1 | 2015-02-26
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