{"id":"079fe547-7b84-4312-8bc0-fc2bbb6f26c8","slug":"ossur-total-knee-2100-recall-2011","kind":"recall","headline":"FDA Class 2 recall of Oessur Total Knee 2100 due to faulty back links","summary":"Oessur initiated a voluntary recall of 142 units of the Total Knee Model 2100 produced from October 19, 2010 to January 21, 2011, after finding that some units contained back links that may compromise knee function prematurely. The recall was distributed worldwide across the US, Europe, Australia, Canada, and Japan. FDA determined the cause as process design.","occurredAt":"2011-02-11T00:00:00.000Z","reviewStatus":"reviewed","modelId":"a1cbcd61-8673-4bdf-8dc0-eee1fea9d6e8","deploymentId":"98502889-6ab9-4546-b9a2-be4db20c5620","companyId":null,"dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"minor","rootCauseCategory":"design_defect","rootCauseDetail":"Some units of the Total Knee 2100 produced from October 19, 2010 until January 21, 2011 contained back links that may compromise knee function prematurely. FDA determined cause as process design.","affectedUnitsCount":142,"affectedUnitsBasis":"exact","remediationStatus":"resolved","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,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-08-16T13:03:24.894Z","updatedAt":"2026-08-23T15:14:15.796Z","model":{"id":"a1cbcd61-8673-4bdf-8dc0-eee1fea9d6e8","companyId":"75a567ec-e23a-47f6-8814-12705a627540","modelName":"Rheo Knee","slug":"embla-rheo-knee","description":"The Rheo Knee is a microprocessor-controlled prosthetic knee that uses artificial intelligence to continuously adapt to the user's gait. 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guide](https://media.ossur.com/ossur-dam/image/upload/v1700036105/product-documents-global/Rheo-Knee_Rheo-Knee-XC_Information-Guide_es-es.pdf)).","sourceUrl":"https://media.ossur.com/ossur-dam/image/upload/v1700036105/product-documents-global/Rheo-Knee_Rheo-Knee-XC_Information-Guide_es-es.pdf"},{"label":"Gait adaptation","value":"Össur says Rheo Knee continuously monitors movement and adapts its response to walking conditions ([Rheo Knee](https://www.ossur.com/en-us/prosthetics/knees/rheo-knee)).","sourceUrl":"https://www.ossur.com/en-us/prosthetics/knees/rheo-knee"},{"label":"Design recognition","value":"Össur reported that Rheo Knee XC received a 2019 iF Design Award ([Össur design award 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product — available for purchase in this market.","keyFacts":[],"reviewNote":"Bulk deepened — form-factor-based metadata 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