{"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. 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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":"bbeb6f20-041b-4c2a-91f1-d23c6d6a85a8","incidentId":"079fe547-7b84-4312-8bc0-fc2bbb6f26c8","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97954","label":"FDA","publishedAt":"2011-03-25T00:00:00.000Z","notes":null,"title":null,"sourceName":"FDA","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-16T13:03:24.894Z","updatedAt":"2026-08-16T13:03:24.894Z"}],"responses":[],"statusEvents":[{"id":"90e8de77-7e73-41b1-856c-4c6b0fde0f46","incidentId":"079fe547-7b84-4312-8bc0-fc2bbb6f26c8","status":"active","reason":null,"source":"agent:recon","effectiveAt":"2026-08-16T13:03:26.055Z","createdAt":"2026-08-16T13:03:26.055Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/ossur-total-knee-2100-recall-2011","url":"https://registry.deploy.report/incidents/ossur-total-knee-2100-recall-2011","headline":"FDA Class 2 recall of Oessur Total Knee 2100 due to faulty back links","description":"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. 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