{"recall":{"id":"fda-device-99691","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"SEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head","firm":"SEASPINE ORTHOPEDICS CORPORATION","date":"2026-08-19","reported":"2026-09-30","status":"Ongoing","classification":"Class II","products":[{"name":"SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12","code":"UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.","quantity":"270 units","number":"Z-3226-2026","classification":"Class II"}],"reason":"The proximal thread depth of the spinal device is out of design specification.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Oklahoma, Oregon, Tennessee, Texas, and Virginia.","nationwide":true,"states":[],"units":"270 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=99691","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"5ecf01b03710d94a","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=99691","record":[{"status":"Ongoing","city":"Carlsbad","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99691","recalling_firm":"SEASPINE ORTHOPEDICS CORPORATION","address_1":"5770 Armada Dr","address_2":"","postal_code":"92008-4608","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Oklahoma, Oregon, Tennessee, Texas, and Virginia.","recall_number":"Z-3226-2026","product_description":"SeaSpine  Mariner Deformity  Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm  REF: MD1-300010-12","product_quantity":"270 units","reason_for_recall":"The proximal thread depth of the spinal device is out of design specification.","recall_initiation_date":"20260819","center_classification_date":"20260918","report_date":"20260930","code_info":"UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.","more_code_info":""}]}}