{"recall":{"id":"fda-device-99405","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model","firm":"Waldemar Link GmbH & Co. KG (Mfg Site)","date":"2026-07-06","reported":"2026-08-19","status":"Ongoing","classification":"Class II","products":[{"name":"Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16","code":"UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069","quantity":"1 US; 9 OUS","number":"Z-2934-2026","classification":"Class II"}],"reason":"The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.","nationwide":false,"states":["IN"],"units":"1 US; 9 OUS","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=99405","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"e3e72762c24c7a9e","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=99405","record":[{"status":"Ongoing","city":"Norderstedt","state":"","country":"Germany","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99405","recalling_firm":"Waldemar Link GmbH & Co. KG (Mfg Site)","address_1":"Ost Str. 4-10","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.","recall_number":"Z-2934-2026","product_description":"Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge  Item Number 15-0027/16","product_quantity":"1 US; 9 OUS","reason_for_recall":"The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.","recall_initiation_date":"20260706","center_classification_date":"20260811","report_date":"20260819","code_info":"UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069","more_code_info":""}]}}