{"recall":{"id":"fda-device-99515","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"F & A Foundation recalls Reign Medical Clench Staple System (Compression)","firm":"F & A Foundation","date":"2026-07-15","reported":"2026-09-23","status":"Ongoing","classification":"Class II","products":[{"name":"Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm x 18mm/152-31818; 20mm x 20mm/152-32020; 9mm x 7mm/152-40907; 11mm x 10mm/152-41110; 15mm x 12mm/152-41512; 18mm x 18mm/152-41818; 20mm x 20mm/152-42020","code":"REF/UDI-DI/Lot/Expiration: 152-30907/00854325007011/24-0627/10/27/2029, 152-31110/00854325007028/24-0628/10/21/2029, 152-31512/00854325007042/24-0629/10/22/2029, 152-31818/00854325007073/24-0630/10/23/2029, 152-32020/00854325007189/24-0631/10/28/2029, 152-40907/00854325007010/24-0633/10/16/2029, 152-41110/00854325007127/24-0634/10/20/2029, 152-41512/00854325007141/24-0635/10/20/2029, 152-41818/00854325007172/24-0636/10/16/2029, 152-42020/00854325007189/24-0637/10/16/2029","quantity":"600","number":"Z-3211-2026","classification":"Class II"}],"reason":"Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA.","nationwide":true,"states":[],"units":"600","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=99515","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"81963f198231a5c7","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=99515","record":[{"status":"Ongoing","city":"Tulsa","state":"OK","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99515","recalling_firm":"F & A Foundation","address_1":"6303 E 102nd St","address_2":"N/A","postal_code":"74137-7041","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"N/A","distribution_pattern":"US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA.","recall_number":"Z-3211-2026","product_description":"Reign Medical Clench Staple System (Compression), Description/REF:   9mm x 7mm/152-30907;   11mm x 10mm/152-31110;  15mm x 12mm/152-31512;  18mm x 18mm/152-31818;  20mm x 20mm/152-32020;  9mm x 7mm/152-40907;  11mm x 10mm/152-41110;  15mm x 12mm/152-41512;   18mm x 18mm/152-41818;  20mm x 20mm/152-42020","product_quantity":"600","reason_for_recall":"Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.","recall_initiation_date":"20260715","center_classification_date":"20260917","report_date":"20260923","code_info":"REF/UDI-DI/Lot/Expiration:  152-30907/00854325007011/24-0627/10/27/2029,  152-31110/00854325007028/24-0628/10/21/2029,  152-31512/00854325007042/24-0629/10/22/2029,  152-31818/00854325007073/24-0630/10/23/2029,  152-32020/00854325007189/24-0631/10/28/2029,  152-40907/00854325007010/24-0633/10/16/2029,  152-41110/00854325007127/24-0634/10/20/2029,  152-41512/00854325007141/24-0635/10/20/2029,  152-41818/00854325007172/24-0636/10/16/2029,  152-42020/00854325007189/24-0637/10/16/2029","more_code_info":""}]}}