{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "187128", "product_res_number": "Z-1594-2021", "event_date_initiated": "2021-04-20", "event_date_created": "2021-05-14", "recall_status": "Open, Classified", "res_event_number": "87825", "product_code": "IPM", "product_description": "Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expulsion valve plus a locking mechanism. Product design features an easy release mechanism. Available with or without a titanium pyramid. The lanyard is part of the Alpha Interlock\" Suspension System. This system allows you to interchange suspension methods without remaking a socket\nModel, 3 part numbers\n- 700-AIS100, Alpha Interlock Suspension System with Alpha Lanyard\n- 700-AIS101, Alpha Interlock Suspension System with Alpha Lanyard w/Titanium Pyramid\n- 700-AIS107, Alpha Interlock Suspension System Lanyard Body ONLY", "code_info": "Lot: 'xx' stamped on the outside of the Lanyard body manufactured form 04/01/2020 - 04/08/2021", "firm_fei_number": "1522166", "recalling_firm": "WillowWood Global Llc", "address_1": "15441 Scioto Darby Rd", "city": "Mount Sterling", "state": "OH", "postal_code": "43143-9036", "additional_info_contact": "Steve Huggins\n740-869-3377 Ext. 200", "reason_for_recall": "the firm discovered that, starting on April 1, 2020, a 3/8 dowel pin was used in place of the 5/8 pin. Over time, the shorter pin may not engage in either the upper or lower body, causing the cord to come loose or slip which could result in the loss of suspension.", "root_cause_description": "Process change control", "action": "On 04/20/2021, Willow Wood issued an Urgent Medical Device Removal notice to customer via letter notifying them it was discovered that, starting on April 1, 2020, a 3/8 dowel pin was used in place of the 5/8 pin. Over time, the shorter pin may not engage in either the upper or lower body, causing the cord to come loose or slip which could result in the loss of suspension.", "product_quantity": "815 parts", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, KS, KY, LA, MA, ME, MN, MO, MS, NJ, NM, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA and the countries of Germany, Netherlands", "openfda": { "k_number": [ "K761114", "K780905", "K872488", "K801627", "K823399", "K770223" ], "registration_number": [ "1030451", "3007510149", "3007076137", "1063411", "3010452421", "3003890514", "1000357070", "3016904853", "1225916", "1922710", "9616872", "2031918", "3017633586", "1824252", "3004122598", "3004905643", "1649518", "3006227741", "3008392711", "3012841710", "3010694026", "3018070833", "3017936957", "9616088", "3017697481", "3025355675", "3008812560", "3045058049", "1834241", "2242474", "3024891479", "1423537", "3003464828", "2024311", "1527846", "3021581046", "1043591", "3045816902", "3014747863", "1836161", "3005276041", "1061153", "3016172261", "3007420886", "2320762", "1000119796", "2133465", "1000228440", "1424263", "3005841961", "3021394836", "3015414875", "3004824601", "1640425", "8030901", "2031823", "3010033845", "3008259931", "3005282622", "3018762595", "1061124", "2545", "1054241", "3030413824", "3003827835", "3045857302", "3010508273", "3010595915", "9613558", "3005621808", "3009417901", "9681133", "9613910", "1063312", "3017264244", "9616086", "3014947080", "3007615436", "3006008854", "3012205931", "3004111573", "9615149", "3016171961", "3009285151", "3004967086", "3004161950", "3007914557", "3011706862", "1055236", "3014421917", "8030607", "3004464325", "3003849847", "1043214", "3029975230", "2950684", "3009068676", "3035642068", "1522166", "3027500264", "3005621301", "1417592", "3045816907", "9616494", "3030541652", "3008016588", "1926174", "3005748450", "2184046", "3004605321", "1058063", "1721652", "3006707030", "3017958535", "3015960622", "3015173212", "1037885", "3015146876", "2027062", "1022826", "1911617", "3008395545", "3006943846", "3006532285", "1060680", "3014658541", "9710020", "3007543825", "1054236", "3014368824", "1928237", "9612243", "1314417", "2028253", "3013002868", "3005012805", "3007392395", "1058311", "3014108257", "3005037196", "8022890", "1058152", "3005190268", "3003764610", "3008564931", "8010822", "3009130317", "2029275", "3011120089", "3004488394", "9680835" ], "fei_number": [ "1030451", "3007510149", "3007076137", "3010452421", "3003890514", "1000357070", "3016904853", "1000220701", "1922710", "3017633586", "3004122598", "3004905643", "1000125378", "3002897187", "3006227741", "3008392711", "3004574120", "3012841710", "3010694026", "3018070833", "3017936957", "3001237801", "1000306431", "3017697481", "1000512168", "3006076154", "3025355675", "3008812560", "3002750084", "3045058049", "2242474", "3024891479", "3003464828", "2024311", "1527846", "4599", "3001236905", "3021581046", "1043591", "3045816902", "3014747863", "3005276041", "3016172261", "3007420886", "1000228440", "3005841961", "3021394836", "3015414875", "3004824601", "1640425", "3001236277", "3010033845", "3008259931", "3005282622", "3018762595", "3003117657", "2545", "3003340795", "3926", "3030413824", "3003827835", "3045857302", "3010508273", "3010595915", "3003702031", "3005621808", "1000307649", "3009417901", "1000112968", "3017264244", "3014947080", "3007615436", "3006008854", "3012205931", "3004111573", "3016171961", "3009285151", "3004967086", "3003050720", "3004161950", "3007914557", "3011706862", "1000208624", "3002298696", "1000112881", "3014421917", "3004464325", "3002757749", "3003849847", "1043214", "3029975230", "3009068676", "3035642068", "1000520282", "1522166", "3027500264", "3005621301", "1000159880", "1417592", "3045816907", "3030541652", "3000719631", "3008016588", "3005150907", "3003215851", "1926174", "3005748450", "3004605321", "1721652", "1000123590", "3006707030", "3017958535", "3015960622", "3015173212", "1037885", "3015146876", "3006509795", "3003015552", "2027062", "1022826", "1911617", "3008395545", "3006943846", "3005564811", "3006532285", "1000115781", "3014658541", "1000512203", "3007543825", "3014368824", "1928237", "3002935344", "1000112877", "1314417", "3013002868", "3005012805", "3003040625", "3007392395", "1000042994", "3014108257", "3005037196", "3005190268", "1000222089", "3003764610", "1000222175", "3008564931", "3009130317", "1000554387", "3002902735", "3011120089", "3004488394" ], "device_name": "Cover, Limb", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.3025", "device_class": "1" } } ] }