{"id":"333fc2ae-2b75-4198-a80c-004d3a2d0a2d","slug":"think-surgical-tmini-tracking-array-recall-2026-05","kind":"recall","headline":"THINK Surgical recalls TMINI tracking arrays due to loosening causing potential misalignment","summary":"THINK Surgical initiated a recall (Z-2716-2026) of TMINI Femur and Tibia Tracking Arrays (REF 109003/109004) because the knob on the tracking array may loosen, causing potential misalignment that could result in incorrect positional information communicated to the TMINI Miniature Robotic System. There have been 11 complaints regarding loose tracking arrays. Customers were instructed to inspect arrays before each use and return loose units.","occurredAt":"2026-05-08T00:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"fcbc42cb-7267-41d7-ab02-10d4838d2a93","dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"moderate","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":"in_progress","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":"2026-08-17T14:04:18.097Z","updatedAt":"2026-08-17T14:04:18.097Z","model":null,"deployment":null,"company":{"id":"fcbc42cb-7267-41d7-ab02-10d4838d2a93","name":"THINK Surgical","slug":"think-surgical","description":"[THINK Surgical](https://thinksurgical.com) is a medical robotics company based in Fremont, California, developing the TMINI Miniature Robotic System for robotic-assisted total knee arthroplasty. The TMINI system is unique in supporting multiple implant manufacturers (Zimmer Biomet, Medacta, Stryker, Maxx Orthopedics, Waldemar Link, b-ONE Ortho) through its proprietary TPLAN software and ID-HUB implant data platform, enabling surgeon choice in robotic orthopedic surgery. The system received FDA 510(k) clearance in May 2023 and has been used in over 5,000 procedures as of May 2026.","status":"private (surgical robots; $105M raised)","founded":2007,"hq":"Fremont, California, USA","hqLat":37.5482697,"hqLng":-121.988571,"hqGeocodedAt":"2026-08-05T14:50:25.251Z","hqAddress":null,"hqPrecision":null,"website":"thinksurgical.com","fundingTotal":"105000000","type":"hardware","reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://thinksurgical.com/think-surgical-receives-fda-510k-clearance-for-tmini-miniature-robotic-system-tmini-1-1/","title":"THINK Surgical Receives FDA 510(k) Clearance for TMINI 1.1","sourceName":"THINK Surgical"}],"keyFacts":[{"label":"Product","value":"TMINI Miniature Robotic System"},{"label":"FDA clearance","value":"510(k) May 2023"},{"label":"Procedures","value":"5000+ (May 2026)"},{"label":"Implant partners","value":"Zimmer Biomet, Medacta, Stryker, Maxx Orthopedics, Waldemar Link, b-ONE Ortho"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":null,"stockExchange":null,"secCik":null,"revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-07-03T14:20:55.194Z","updatedAt":"2026-08-05T14:52:46.279Z"},"derived":{"status":"active"},"sources":[{"id":"bb2ee06a-2a73-4973-bd5e-4eba01905d16","incidentId":"333fc2ae-2b75-4198-a80c-004d3a2d0a2d","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99219","label":"FDA","publishedAt":"2026-07-09T00:00:00.000Z","notes":null,"title":null,"sourceName":"FDA","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-17T14:04:18.097Z","updatedAt":"2026-08-17T14:04:18.097Z"}],"responses":[],"statusEvents":[{"id":"325ff489-4f74-40ea-8705-f5d4eaad6027","incidentId":"333fc2ae-2b75-4198-a80c-004d3a2d0a2d","status":"active","reason":null,"source":"agent:recon","effectiveAt":"2026-08-17T14:04:19.242Z","createdAt":"2026-08-17T14:04:19.242Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/think-surgical-tmini-tracking-array-recall-2026-05","url":"https://registry.deploy.report/incidents/think-surgical-tmini-tracking-array-recall-2026-05","headline":"THINK Surgical recalls TMINI tracking arrays due to loosening causing potential misalignment","description":"THINK Surgical initiated a recall (Z-2716-2026) of TMINI Femur and Tibia Tracking Arrays (REF 109003/109004) because the knob on the tracking array may loosen, causing potential misalignment that could result in incorrect positional information communicated to the TMINI Miniature Robotic System. There have been 11 complaints regarding loose tracking arrays. Customers were instructed to inspect arrays before each use and return loose units.","identifier":"333fc2ae-2b75-4198-a80c-004d3a2d0a2d","datePublished":"2026-05-08T00:00:00.000Z","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"]}}}