{"id":"21b2e025-7878-41cf-847c-921ba5ab2781","slug":"rewalk-personal-6-tibia-fibula-injury-recall-2017","kind":"recall","headline":"ReWalk (now Lifeward) recalls Personal 6.0 exoskeleton after tibia and fibula injury complaints","summary":"ReWalk Robotics received complaints of tibia and fibula injury associated with use of the ReWalk Personal 6.0 powered exoskeleton (distributed Sept 2015 to Sept 2017). ReWalk rebranded to Lifeward in 2024. Source: FDA Class 2 device recall Z-0944-2018 (127 units; device K160987), accessdata.fda.gov.","occurredAt":"2017-08-14T00:00:00.000Z","reviewStatus":"reviewed","modelId":"2f847d21-9b21-4ce0-bb03-6d2bd97ae10b","deploymentId":"28a404b5-9f66-4176-bc97-0157d71d22bf","companyId":"4421900a-d71f-407e-a37c-ad1e3905e97f","dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"serious","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":127,"affectedUnitsBasis":"exact","remediationStatus":null,"regulatoryAction":"recall_ordered","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":2,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-06-27T09:38:44.877Z","updatedAt":"2026-08-09T05:24:01.599Z","model":{"id":"2f847d21-9b21-4ce0-bb03-6d2bd97ae10b","companyId":"4421900a-d71f-407e-a37c-ad1e3905e97f","modelName":"ReWalk 7","slug":"rewalk-7","description":"Powered lower-limb personal exoskeleton; latest ReWalk generation, FDA cleared March 2025. Motor-driven powered gait for spinal-cord-injury users.","formFactor":"exoskeleton","industryVertical":null,"environment":null,"maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{"use":"medical (personal, SCI)","control":"weight-shift triggered powered gait","powered":"yes (motor-driven)","regulatory":"FDA cleared 2025-03","body_region":"lower-limb","availability":"commercial (2025 launch)"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://ir.golifeward.com/news-releases/news-release-details/fda-issues-clearance-rewalk-7-exoskeleton","title":"ReWalk 7 (FDA clearance 2025)","sourceName":"Lifeward (primary)"},{"url":"https://golifeward.com/","title":"Lifeward (official)","sourceName":"Lifeward (primary)"}],"aliases":["ReWalk 7"],"collisionRisk":"low","reviewNote":"reverified 2026-06-09 (Kimi-incident remediation): cited primary source resolves and matches manufacturer/reputable domain; relevance adjudicated.","manufacturerTermForTeleop":null,"keyFacts":[{"label":"Type","value":"Exoskeleton for rehabilitation"}],"createdAt":"2026-06-06T01:25:40.609Z","updatedAt":"2026-07-08T20:09:21.124Z","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":{"id":"28a404b5-9f66-4176-bc97-0157d71d22bf","modelId":"d59824bf-88ca-4eea-b027-88b11c7fdee3","versionId":null,"locationId":"c1051b93-f4e0-4483-80d0-e67d4737df1f","operatorId":"4421900a-d71f-407e-a37c-ad1e3905e97f","ownerId":null,"slug":"rewalk-personal-6-home-use-us","status":"operational","firstSeen":"2024-06-01T00:00:00.000Z","statusChangeReason":null,"contractType":null,"pilotOutcome":null,"endedAt":null,"unitsOnSite":null,"tasksPerformed":["autonomous_operation"],"shiftStructure":null,"hoursPerDay":8,"siteType":"urban","operatorConfirmed":false,"humanSupervisionOnsite":null,"locationPrecisionTier":"verified_coordinates","deploymentScale":"medium_11_100","siteEnvironment":"outdoor","operatorType":"maker_operated","sourceQualityTier":2,"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://rewalk.com/","title":"ReWalk","date_accessed":"2026-06-07"},{"url":"https://ir.rewalk.com/news-releases/news-release-details/department-veterans-affairs-purchases-20-rewalk-systems-support","title":"Department of Veterans Affairs Purchases 20 ReWalk Systems","retrievedAt":"2026-06-27T12:00:00Z"},{"url":"https://rewalk.com/blog/u-s-department-of-veterans-affairs-expands-access-to-rewalk-exoskeletons-for-paralyzed-veterans-with-revised-national-policy/","title":"U.S. Department of Veterans Affairs Expands Access to ReWalk Exoskeletons","retrievedAt":"2026-06-27T12:00:00Z"}],"notes":"ReWalk Personal 6.0 exoskeleton home-use deployments across US. FDA-cleared for spinal cord injury patients at home and community.","keyFacts":[{"label":"Fleet","value":"ReWalk Personal 6.0 exoskeleton"},{"label":"Coverage","value":"Home-use deployments across US"},{"label":"Use Case","value":"Spinal cord injury patients at home and community"},{"label":"Regulatory","value":"FDA-cleared"}],"reviewNote":null,"exposureHours":null,"deploymentMilesEstimate":null,"exposureBasis":null,"customerSegment":"research","scaleTier":"commercial_10_99","contractValueUsd":null,"contractValueBasis":null,"customerCompanyId":null,"customerExternalName":null,"createdAt":"2026-06-07T22:54:26.859Z","updatedAt":"2026-08-21T14:21:33.821Z"},"company":{"id":"4421900a-d71f-407e-a37c-ad1e3905e97f","name":"Lifeward","slug":"lifeward","description":"Lifeward (formerly [Rewalk robotics](/companies/rewalk-robotics), Nasdaq: LFWD) is an Israeli-American medical device company founded in 2001 by Dr. Amit Goffer, a quadriplegic inventor who developed the exoskeleton after an ATV accident. The company designs and commercializes powered exoskeleton systems for individuals with spinal cord injury, including the ReWalk 7 Personal Exoskeleton (FDA-cleared March 2025) and the ReWalk Personal 6.0. Lifeward's portfolio also includes the AlterG Anti-Gravity System, ReStore Exo-Suit, and MyoCycle FES System, with operations in the US, Israel, and Germany.","status":"public (NASDAQ: LFWD; formerly ReWalk Robotics, RWLK)","founded":2001,"hq":"Marlborough, MA, USA / Yokneam Ilit, Israel","hqLat":null,"hqLng":null,"hqGeocodedAt":"2026-08-05T00:51:10.902Z","hqAddress":null,"hqPrecision":null,"website":"alterg.com","fundingTotal":null,"type":"hardware","roles":["robot_maker","robot_operator"],"reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://ir.rewalk.com/news-releases/news-release-details/rewalk-robotics-transforms-company-identity-rebrands-lifeward","title":"Lifeward","sourceName":"Lifeward (primary)"},{"url":"https://golifeward.com/blog/rewalk-personal-exoskeleton-system-clearned-fda-home-use/","title":"ReWalk Personal 6.0 FDA home-use","sourceName":"Lifeward (primary)"},{"url":"https://ir.rewalk.com/news-releases/news-release-details/lifeward-names-mark-grant-new-ceo","label":"Lifeward Names Mark Grant as New CEO","title":"Lifeward Names Mark Grant as New CEO","mediaType":"article","sourceName":"Lifeward (official IR)"},{"url":"https://golifeward.com/blog/lifeward-launches-sales-of-the-rewalk-7-personal-exoskeleton-in-u-s-market/","label":"Lifeward Launches Sales of the ReWalk 7 Personal Exoskeleton in U.S. Market","title":"Lifeward Launches Sales of the ReWalk 7 Personal Exoskeleton in U.S. Market","mediaType":"article","sourceName":"Lifeward (official)"},{"url":"https://www.sec.gov/Archives/edgar/data/1607962/000117891325000736/zk2532799.htm","label":"Lifeward Ltd. SEC Filing 2025","title":"Lifeward Ltd. SEC Filing 2025","mediaType":"article","sourceName":"SEC EDGAR"}],"keyFacts":[{"label":"CEO","value":"Mark Grant (since June 2025)"},{"label":"Previous CEO","value":"Larry Jasinski"},{"label":"CFO","value":"Mike Lawless"},{"label":"Founder","value":"Dr. Amit Goffer (deceased) — quadriplegic Israeli inventor"},{"label":"Ticker","value":"NASDAQ: LFWD"},{"label":"Revenue 2024","value":"Approximately 25.3 million USD"},{"label":"Units deployed","value":"131 rehabilitation units + 689 personal exoskeleton units (as of Dec 2024)"},{"label":"FDA clearance","value":"ReWalk 7 cleared March 2025; first FDA-cleared exoskeleton in 2014"},{"label":"Medicare","value":"CMS reimbursement pathway established 2024"},{"label":"Operations","value":"United States, Israel, Germany"},{"label":"Product portfolio","value":"ReWalk 7, ReWalk Personal 6.0, AlterG Anti-Gravity, ReStore Exo-Suit, MyoCycle FES"}],"aliases":["ReWalk Robotics","ReWalk"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":"LFWD","stockExchange":"NASDAQ","secCik":"0001607962","revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-06-06T01:25:37.810Z","updatedAt":"2026-08-21T22:24:00.932Z"},"derived":{"status":"active"},"sources":[{"id":"1085f045-51a2-404f-8fee-efa19d6380f4","incidentId":"21b2e025-7878-41cf-847c-921ba5ab2781","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&firmlegalnam=ReWalk&postdatefrom=01/01/2016&postdateto=12/31/2018","label":null,"publishedAt":null,"notes":null,"title":"FDA Recalls — ReWalk (2016-2018)","sourceName":"FDA","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-22T01:56:27.101Z","updatedAt":"2026-07-22T01:56:27.101Z"}],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/rewalk-personal-6-tibia-fibula-injury-recall-2017","url":"https://registry.deploy.report/incidents/rewalk-personal-6-tibia-fibula-injury-recall-2017","headline":"ReWalk (now Lifeward) recalls Personal 6.0 exoskeleton after tibia and fibula injury complaints","description":"ReWalk Robotics received complaints of tibia and fibula injury associated with use of the ReWalk Personal 6.0 powered exoskeleton (distributed Sept 2015 to Sept 2017). ReWalk rebranded to Lifeward in 2024. Source: FDA Class 2 device recall Z-0944-2018 (127 units; device K160987), accessdata.fda.gov.","identifier":"21b2e025-7878-41cf-847c-921ba5ab2781","datePublished":"2017-08-14T00:00:00.000Z","articleSection":"recall","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"verified","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"]}}}