{"id":"29efc6a3-6a01-4a78-846d-bfd93c102354","slug":"recall-2024-03-25-ossur","kind":"recall","headline":"Össur recalls Rheo Knee prosthetic devices due to safety concern","summary":"Össur initiated a recall of Rheo Knee prosthetic devices beginning March 25, 2024, as reported in Biomedical Safety & Standards. The recall affected specific Rheo Knee models (RKN130002) manufactured by Össur H/F in Reykjavik, Iceland.","occurredAt":"2024-03-25T12:00:00.000Z","reviewStatus":"unreviewed","modelId":"8e0a1d03-9601-4df4-9532-2cb2ee937c91","deploymentId":null,"companyId":"57cc5ad0-eda8-46e7-8723-a62d2dd81b86","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"moderate","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"recall_ordered","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":null,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"createdAt":"2026-07-07T15:06:55.666Z","updatedAt":"2026-07-07T15:06:55.666Z","model":{"id":"8e0a1d03-9601-4df4-9532-2cb2ee937c91","companyId":"57cc5ad0-eda8-46e7-8723-a62d2dd81b86","modelName":"Power Knee","slug":"ossur-power-knee","description":"Ossur's Power Knee is described as the world's first actively powered microprocessor prosthetic knee for above-knee amputees; a motor-powered 'smart' prosthesis that detects movement patterns and adapts to the wearer's speed and cadence in real time, enabling step-over-step stair ascent.","formFactor":"wearable","maturityStage":null,"lifecycleState":"active","supersededByModelId":null,"specs":{"class":"powered microprocessor prosthetic knee","power":"motorized"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.ossur.com/en-us/prosthetics/knees/power-knee","sourceName":"Ossur"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[{"label":"Form factor","value":"wearable"},{"label":"Class","value":"powered microprocessor prosthetic knee"},{"label":"Power","value":"motorized"},{"label":"Target user","value":"above-knee amputees"}],"createdAt":"2026-06-24T08:54:35.645Z","updatedAt":"2026-06-28T16:51:19.723Z","unitsInFieldClaimed":null,"unitsInFieldVerified":null,"unitsManufacturedClaimed":null,"unitsManufacturedVerified":null,"unitsAsOf":null,"unitsSource":null,"salesModel":null,"priceUndisclosedSince":null,"autonomyClass":null,"autonomyStatement":null,"autonomyStatementSource":null,"demoForensics":null,"exportControlClass":null,"minCommitment":null,"warrantyTerms":null,"serviceModel":null,"productionRateClaimed":null,"productionRateEvidenced":null,"teleopRatioDisclosed":null,"interventionRateDisclosed":null},"deployment":null,"company":{"id":"57cc5ad0-eda8-46e7-8723-a62d2dd81b86","name":"Ossur","slug":"ossur","description":"Össur (now part of [Embla Medical](https://emblamedical.com)) is an Icelandic medical device company based in Reykjavik, developing bionic prosthetics and non-invasive orthopaedic bracing. Founded in 1971 by amputee and prosthetist Össur Kristinsson, the company pioneered the world's first silicone prosthetic liner (Iceross) and later introduced bionic prosthetics including the [Power Knee](/models/power-knee), Rheo Knee, and Proprio Foot with AI-powered real-time gait adaptation. Listed on Nasdaq Copenhagen (EMBLA) since 2009, with annual revenues exceeding USD 600 million and approximately 4,000 employees across 26 global operations.","status":"active","founded":1971,"hq":"Reykjavik, Iceland","fundingTotal":"60000000","type":"both","reviewStatus":"reviewed","sources":[{"url":"https://www.ossur.com/en-us/prosthetics/knees/power-knee","title":"Ossur Power Knee","date_accessed":"2026-06-24"}],"keyFacts":[{"label":"Focus","value":"Medical-device and bionics company specializing in bionic prosthetics"},{"label":"Parent","value":"Embla Medical (Nasdaq Copenhagen: EMBLA)"},{"label":"Robot","value":"Power Knee, the first actively powered microprocessor prosthetic knee"},{"label":"Technology","value":"Detects movement patterns and adjusts to wearer's speed and cadence in real time"},{"label":"CEO","value":"Jon Sigurdsson"},{"label":"Founder","value":"Össur Kristinsson"},{"label":"Revenue","value":"USD 613M (2018)"},{"label":"IPO","value":"1999 (Iceland Stock Exchange, largest Icelandic IPO at the time)"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"createdAt":"2026-06-24T08:54:33.980Z","updatedAt":"2026-07-07T15:07:09.824Z"},"derived":{"status":"active"},"sources":[{"id":"9fab168a-4291-4d84-ab6f-b5ab2cb08f3f","incidentId":"29efc6a3-6a01-4a78-846d-bfd93c102354","url":"https://www.ovid.com/jnls/biomedicalsafetystandards/pdf/10.1097/01.bmsas.0001026068.32003.c2~link-established-between-tattoos-and-risk-of-lymphomaauthors","label":null,"publishedAt":null,"notes":null,"title":"Össur Prosthetic Knees Recall","sourceName":"Biomedical Safety & Standards","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-07T15:06:56.048Z","updatedAt":"2026-07-07T15:06:56.048Z"}],"responses":[],"statusEvents":[{"id":"4fcd91f2-fdd7-4222-8cc0-28169b4d25c6","incidentId":"29efc6a3-6a01-4a78-846d-bfd93c102354","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-07T15:06:56.430Z","createdAt":"2026-07-07T15:06:56.431Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/recall-2024-03-25-ossur","url":"https://registry.deploy.report/incidents/recall-2024-03-25-ossur","headline":"Össur recalls Rheo Knee prosthetic devices due to safety concern","description":"Össur initiated a recall of Rheo Knee prosthetic devices beginning March 25, 2024, as reported in Biomedical Safety & Standards. The recall affected specific Rheo Knee models (RKN130002) manufactured by Össur H/F in Reykjavik, Iceland.","identifier":"29efc6a3-6a01-4a78-846d-bfd93c102354","datePublished":"2024-03-25T12:00:00.000Z","articleSection":"recall","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"unreviewed","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":1,"primary_source_types":[]}}}