{"recall":{"id":"fda-device-99383","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Arrowhead DE LLC recalls Arrow-LOK Implant","firm":"Arrowhead DE LLC","date":"2026-06-23","reported":"2026-08-26","status":"Ongoing","classification":"Class II","products":[{"name":"Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-353513, 21-353516, 27-253519, 27-253522, 27-253525, 27-253528, 27-253530, 27-253533, 27-253535. Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures.","code":"REF/UDI-DI/Lot: 21-253519/00855967006035/24662119, 242162; 21-253522/00855967006042/24662122, 242163, 220702; 21-253525/00855967006059/24662125, 220703, 242164; 21-253528/00855967006066/24662128, 242165, 230704; 21-253530/00855967006073/242166, 230705, 220705; 21-253533/00855967006080/24662133, 242167, 230706; 21-253535/00855967006097/24662135, 242168, 230707; 21-253540/00855967006110/242169; 21-253545/00855967006127/242170; 21-253550/00855967006134/24662150; 21-353513/00855967006004/24662113, 242160; 21-353516/00855967006011/24662116, 230701, 242161; 27-253519/00855967006028/24662719, 242171; 27-253522/00855967006141/242172; 27-253525/00855967006158/242173; 27-253528/00855967006165/242174; 27-253530/00855967006172/242175; 27-253533/00855967006189/24662733, 242176; 27-253535/00855967006196/24662735, 242177","quantity":"4,171","number":"Z-2958-2026","classification":"Class II"}],"reason":"Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI.","nationwide":true,"states":[],"units":"4,171","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=99383","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"96512c37f501b307","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=99383","record":[{"status":"Ongoing","city":"Peachtree City","state":"GA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99383","recalling_firm":"Arrowhead DE LLC","address_1":"401 Westpark Ct Ste 200","address_2":"","postal_code":"30269-3572","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"US Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI.","recall_number":"Z-2958-2026","product_description":"Arrow-LOK Implant, REF:  21-253519,  21-253522,  21-253525,  21-253528,  21-253530,  21-253533,  21-253535,  21-253540,  21-253545,  21-253550,  21-353513,  21-353516,  27-253519,  27-253522,  27-253525,  27-253528,  27-253530,  27-253533,  27-253535.  Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures.","product_quantity":"4,171","reason_for_recall":"Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.","recall_initiation_date":"20260623","center_classification_date":"20260814","report_date":"20260826","code_info":"REF/UDI-DI/Lot: 21-253519/00855967006035/24662119, 242162;  21-253522/00855967006042/24662122, 242163, 220702;  21-253525/00855967006059/24662125, 220703, 242164;  21-253528/00855967006066/24662128, 242165, 230704;  21-253530/00855967006073/242166, 230705, 220705;  21-253533/00855967006080/24662133, 242167, 230706;  21-253535/00855967006097/24662135, 242168, 230707;  21-253540/00855967006110/242169;  21-253545/00855967006127/242170;  21-253550/00855967006134/24662150;  21-353513/00855967006004/24662113, 242160;  21-353516/00855967006011/24662116, 230701, 242161;  27-253519/00855967006028/24662719, 242171;  27-253522/00855967006141/242172;  27-253525/00855967006158/242173;  27-253528/00855967006165/242174;  27-253530/00855967006172/242175;  27-253533/00855967006189/24662733, 242176;  27-253535/00855967006196/24662735, 242177","more_code_info":""}]}}