{"recall":{"id":"fda-device-99225","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Orthofix U.S. LLC recalls 4 products","firm":"Orthofix U.S. LLC","date":"2026-06-10","reported":"2026-07-22","status":"Ongoing","classification":"Class II","products":[{"name":"Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device","code":"All Lots; GTIN# 18032568866636;","quantity":"48 units","number":"Z-2729-2026","classification":"Class II"},{"name":"Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device","code":"All Lots/GTIN# 18032568866650","quantity":"19 units","number":"Z-2730-2026","classification":"Class II"},{"name":"Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device","code":"All Lots; GTIN# 18032568866681","quantity":"32 units","number":"Z-2731-2026","classification":"Class II"},{"name":"Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device","code":"All Lots; GTIN# 18032568866711","quantity":"62 units","number":"Z-2732-2026","classification":"Class II"}],"reason":"Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US: AZ\tCA\tCO\tCT\tFL\tGA\tID\tIL\tIN\tLA\tMD\tMI\tMO\tMS\tMT\tNC\tNY\tOH\tOR\tSC\tSD\tTX\tUT\tVA\tWA\tWI\t  OUS: None","nationwide":false,"states":["AZ","CA","CO","CT","FL","GA","ID","IL","IN","LA","MD","MI","MO","MS","MT","NC","NY","OH","OR","SC","SD","TX","UT","VA","WA","WI"],"units":"48 units; 19 units; 32 units; 62 units","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99225","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"e5a8eb4e8addd34f","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99225","record":[{"status":"Ongoing","city":"Lewisville","state":"TX","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99225","recalling_firm":"Orthofix U.S. LLC","address_1":"3451 Plano Pkwy","address_2":"","postal_code":"75056-9453","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US: AZ\tCA\tCO\tCT\tFL\tGA\tID\tIL\tIN\tLA\tMD\tMI\tMO\tMS\tMT\tNC\tNY\tOH\tOR\tSC\tSD\tTX\tUT\tVA\tWA\tWI\t  OUS: None","recall_number":"Z-2729-2026","product_description":"Orthofix MINIRAIL, STANDARD LENGTHENER  Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device","product_quantity":"48 units","reason_for_recall":"Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111","recall_initiation_date":"20260610","center_classification_date":"20260714","report_date":"20260722","code_info":"All Lots; GTIN# 18032568866636;","more_code_info":""},{"status":"Ongoing","city":"Lewisville","state":"TX","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99225","recalling_firm":"Orthofix U.S. LLC","address_1":"3451 Plano Pkwy","address_2":"","postal_code":"75056-9453","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US: AZ\tCA\tCO\tCT\tFL\tGA\tID\tIL\tIN\tLA\tMD\tMI\tMO\tMS\tMT\tNC\tNY\tOH\tOR\tSC\tSD\tTX\tUT\tVA\tWA\tWI\t  OUS: None","recall_number":"Z-2730-2026","product_description":"Orthofix MINIRAIL, SHORT, LENGTHENER  REF: M103, Unilateral orthopedic/trauma external fixation device","product_quantity":"19 units","reason_for_recall":"Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111","recall_initiation_date":"20260610","center_classification_date":"20260714","report_date":"20260722","code_info":"All Lots/GTIN# 18032568866650","more_code_info":""},{"status":"Ongoing","city":"Lewisville","state":"TX","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99225","recalling_firm":"Orthofix U.S. LLC","address_1":"3451 Plano Pkwy","address_2":"","postal_code":"75056-9453","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US: AZ\tCA\tCO\tCT\tFL\tGA\tID\tIL\tIN\tLA\tMD\tMI\tMO\tMS\tMT\tNC\tNY\tOH\tOR\tSC\tSD\tTX\tUT\tVA\tWA\tWI\t  OUS: None","recall_number":"Z-2731-2026","product_description":"Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS  REF: M111, Unilateral orthopedic/trauma external fixation device","product_quantity":"32 units","reason_for_recall":"Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111","recall_initiation_date":"20260610","center_classification_date":"20260714","report_date":"20260722","code_info":"All Lots; GTIN# 18032568866681","more_code_info":""},{"status":"Ongoing","city":"Lewisville","state":"TX","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99225","recalling_firm":"Orthofix U.S. LLC","address_1":"3451 Plano Pkwy","address_2":"","postal_code":"75056-9453","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US: AZ\tCA\tCO\tCT\tFL\tGA\tID\tIL\tIN\tLA\tMD\tMI\tMO\tMS\tMT\tNC\tNY\tOH\tOR\tSC\tSD\tTX\tUT\tVA\tWA\tWI\t  OUS: None","recall_number":"Z-2732-2026","product_description":"Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS  REF: M122, Unilateral orthopedic/trauma external fixation device","product_quantity":"62 units","reason_for_recall":"Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111","recall_initiation_date":"20260610","center_classification_date":"20260714","report_date":"20260722","code_info":"All Lots; GTIN# 18032568866711","more_code_info":""}]}}