{"recall":{"id":"fda-device-99221","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"SEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Polyaxial Head REF Number: 41-3010","firm":"SEASPINE ORTHOPEDICS CORPORATION","date":"2026-05-28","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"SeaSpine Polyaxial Head REF Number: 41-3010","code":"UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.","quantity":"796 units","number":"Z-2762-2026","classification":"Class II"}],"reason":"Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, Mississippi, Montana, Nevada, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and Wyoming. The countries of Chile and Australia.","nationwide":true,"states":[],"units":"796 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=99221","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"32eee29136f6e517","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=99221","record":[{"status":"Ongoing","city":"Carlsbad","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99221","recalling_firm":"SEASPINE ORTHOPEDICS CORPORATION","address_1":"5770 Armada Dr","address_2":"N/A","postal_code":"92008-4608","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"N/A","distribution_pattern":"Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, Mississippi, Montana, Nevada, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and Wyoming. The countries of Chile and Australia.","recall_number":"Z-2762-2026","product_description":"SeaSpine Polyaxial Head  REF Number: 41-3010","product_quantity":"796 units","reason_for_recall":"Due to manufacturing error, polyaxial  head may popoff  from the screw intraoperatively following insertion.","recall_initiation_date":"20260528","center_classification_date":"20260720","report_date":"20260729","code_info":"UDI: 10889981155117; Affected Lots: AW199682G, AW199684G."}]}}