{"recall":{"id":"fda-device-99346","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Biomet, Inc. recalls 5 products","firm":"Biomet, Inc.","date":"2026-07-01","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm","code":"UDI-DI (01)00887868507793(17)360407(10)67818791; Lot 67818791","quantity":"10","number":"Z-2867-2026","classification":"Class II"},{"name":"Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm","code":"UDI-DI (01)00887868507809(17)360228(10)67818772; Lot 67818772","quantity":"12","number":"Z-2868-2026","classification":"Class II"},{"name":"Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm","code":"UDI-DI (01)00887868507816(17)360221(10)67818764; Lot 67818764 Model No 475630; UDI-DI (01)00887868507816(17)360401(10)67818768; Lot 67818768 Model No 475630; UDI-DI (01)00887868507816(17)360428(10)67954534; Lot 67954534","quantity":"26","number":"Z-2869-2026","classification":"Class II"},{"name":"Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm","code":"UDI-DI (01)00887868507823(17)360224(10)67818769; Lot 67818769 Model No 475635; UDI-DI (01)00887868507823(17)360225(10)67818770; Lot 67818770","quantity":"22","number":"Z-2870-2026","classification":"Class II"},{"name":"Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm","code":"UDI-DI (01)00887868507830(17)360316(10)67818792; Lot 67818792","quantity":"11","number":"Z-2871-2026","classification":"Class II"}],"reason":"Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Refer to the attached ZFA 2026-00096_Initial Consignee List and ZFA 2026-00096_Initial Distribution History containing the distribution and the identification of the affected consignees.","nationwide":false,"states":[],"units":"10; 12; 26; 22; 11","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=99346","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"8a76c1e36d5c008e","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=99346","record":[{"status":"Ongoing","city":"Warsaw","state":"IN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99346","recalling_firm":"Biomet, Inc.","address_1":"56 E Bell Dr","address_2":"","postal_code":"46582-6989","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Refer to the attached ZFA 2026-00096_Initial Consignee List and ZFA 2026-00096_Initial Distribution History containing the distribution and the identification of the affected consignees.","recall_number":"Z-2867-2026","product_description":"Intramedullary Bone Saw Blade Assembly  Model/Catalog Number: 475620  Product Description: Intramedullary Bone Saw Blade Assembly 12mm","product_quantity":"10","reason_for_recall":"Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.","recall_initiation_date":"20260701","center_classification_date":"20260803","report_date":"20260812","code_info":"UDI-DI (01)00887868507793(17)360407(10)67818791; Lot 67818791","more_code_info":""},{"status":"Ongoing","city":"Warsaw","state":"IN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99346","recalling_firm":"Biomet, Inc.","address_1":"56 E Bell Dr","address_2":"","postal_code":"46582-6989","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Refer to the attached ZFA 2026-00096_Initial Consignee List and ZFA 2026-00096_Initial Distribution History containing the distribution and the identification of the affected consignees.","recall_number":"Z-2868-2026","product_description":"Intramedullary Bone Saw Blade Assembly  Model/Catalog Number: 475625  Product Description: Intramedullary Bone Saw Blade Assembly 13mm","product_quantity":"12","reason_for_recall":"Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.","recall_initiation_date":"20260701","center_classification_date":"20260803","report_date":"20260812","code_info":"UDI-DI (01)00887868507809(17)360228(10)67818772; Lot 67818772","more_code_info":""},{"status":"Ongoing","city":"Warsaw","state":"IN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99346","recalling_firm":"Biomet, Inc.","address_1":"56 E Bell Dr","address_2":"","postal_code":"46582-6989","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Refer to the attached ZFA 2026-00096_Initial Consignee List and ZFA 2026-00096_Initial Distribution History containing the distribution and the identification of the affected consignees.","recall_number":"Z-2869-2026","product_description":"Intramedullary Bone Saw Blade Assembly  Model/Catalog Number: 475630  Product Description: Intramedullary Bone Saw Blade Assembly 14mm","product_quantity":"26","reason_for_recall":"Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.","recall_initiation_date":"20260701","center_classification_date":"20260803","report_date":"20260812","code_info":"UDI-DI (01)00887868507816(17)360221(10)67818764; Lot 67818764 Model No 475630; UDI-DI (01)00887868507816(17)360401(10)67818768; Lot 67818768 Model No 475630; UDI-DI (01)00887868507816(17)360428(10)67954534; Lot 67954534","more_code_info":""},{"status":"Ongoing","city":"Warsaw","state":"IN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99346","recalling_firm":"Biomet, Inc.","address_1":"56 E Bell Dr","address_2":"","postal_code":"46582-6989","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Refer to the attached ZFA 2026-00096_Initial Consignee List and ZFA 2026-00096_Initial Distribution History containing the distribution and the identification of the affected consignees.","recall_number":"Z-2870-2026","product_description":"Intramedullary Bone Saw Blade Assembly  Model/Catalog Number: 475635  Product Description: Intramedullary Bone Saw Blade Assembly 15mm","product_quantity":"22","reason_for_recall":"Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.","recall_initiation_date":"20260701","center_classification_date":"20260803","report_date":"20260812","code_info":"UDI-DI (01)00887868507823(17)360224(10)67818769; Lot 67818769 Model No 475635; UDI-DI (01)00887868507823(17)360225(10)67818770; Lot 67818770","more_code_info":""},{"status":"Ongoing","city":"Warsaw","state":"IN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99346","recalling_firm":"Biomet, Inc.","address_1":"56 E Bell Dr","address_2":"","postal_code":"46582-6989","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Refer to the attached ZFA 2026-00096_Initial Consignee List and ZFA 2026-00096_Initial Distribution History containing the distribution and the identification of the affected consignees.","recall_number":"Z-2871-2026","product_description":"Intramedullary Bone Saw Blade Assembly  Model/Catalog Number: 475640  Product Description: Intramedullary Bone Saw Blade Assembly 16mm","product_quantity":"11","reason_for_recall":"Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.","recall_initiation_date":"20260701","center_classification_date":"20260803","report_date":"20260812","code_info":"UDI-DI (01)00887868507830(17)360316(10)67818792; Lot 67818792","more_code_info":""}]}}