{"id":"015ef41a-2185-4ffb-b87c-67bcecb5391c","slug":"ossur-total-knee-junior-recall-2009","kind":"recall","headline":"FDA Class 2 recall of Össur Total Knee Junior prosthetic knee due to balancing unit failure","summary":"Össur initiated a Class 2 recall of 141 units of the Total Knee Junior prosthetic knee produced between November 2008 and April 2009. The balancing units could fail under extreme use over a long period (estimated 4-6 years). No incidents or injuries were reported at the time of recall. 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It provides real-time variable damping for natural movement across different walking speeds and terrain types.","formFactor":"other","industryVertical":null,"environment":null,"maturityStage":"production","lifecycleState":"active","supersededByModelId":null,"specs":{},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.ossur.com/en-us/prosthetics/products/rheo-knee","label":"Rheo Knee - Össur","title":"Rheo Knee - Össur","mediaType":"article","sourceName":"ossur.com"},{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=84735","title":"FDA Class 2 Recall — Össur Total Knee Junior prosthetic knee","sourceName":"FDA"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[],"createdAt":"2026-07-28T23:07:03.917Z","updatedAt":"2026-07-29T09:23:18.988Z","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":null,"derived":{"status":"active"},"sources":[{"id":"02e7fcae-3d90-4ed6-b26e-d50d4246f882","incidentId":"015ef41a-2185-4ffb-b87c-67bcecb5391c","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=84735","label":"FDA MAUDE Database","publishedAt":"2012-02-06T00:00:00.000Z","notes":null,"title":null,"sourceName":"FDA MAUDE Database","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-28T23:07:17.096Z","updatedAt":"2026-07-28T23:07:17.096Z"}],"responses":[],"statusEvents":[{"id":"bf5c260a-9494-43af-8fdd-a4e14129f66a","incidentId":"015ef41a-2185-4ffb-b87c-67bcecb5391c","status":"active","reason":null,"source":"agent:recon","effectiveAt":"2026-07-28T23:07:18.237Z","createdAt":"2026-07-28T23:07:18.237Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/ossur-total-knee-junior-recall-2009","url":"https://registry.deploy.report/incidents/ossur-total-knee-junior-recall-2009","headline":"FDA Class 2 recall of Össur Total Knee Junior prosthetic knee due to balancing unit failure","description":"Össur initiated a Class 2 recall of 141 units of the Total Knee Junior prosthetic knee produced between November 2008 and April 2009. The balancing units could fail under extreme use over a long period (estimated 4-6 years). No incidents or injuries were reported at the time of recall. The recall was terminated on February 6, 2012.","identifier":"015ef41a-2185-4ffb-b87c-67bcecb5391c","datePublished":"2009-08-10T00:00:00.000Z","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":["primary-fda-database"]}}}