{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "122155", "product_res_number": "Z-0098-2014", "event_date_initiated": "2013-09-06", "event_date_posted": "2013-10-29", "recall_status": "Terminated", "event_date_terminated": "2015-03-30", "res_event_number": "66362", "product_code": "KWI", "k_numbers": [ "K002644", "K010786", "K011819", "K062898", "K070236", "K982288" ], "product_description": "Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma Coated, rHead Recon Radial Stem Plasma Coated, rHead Radial Stem 6mm Collar Plasma Coated, rHead Recon Radial Stem 6mm Collar Plasma Coated, uHead Ulnar Stem Standard, uHead Ulnar Stem 20mm Collar packaged in a sterile pouch inside a shrink-wrapped box. \n\nThe recall was expanded on December 20, 2013 to include the following devices: rHead lateral assembly, radial head implant, sizes 2 through 4, Uni-elbow lateral assembly, radial implant assembly, sozes 2 through 4, ReMotion Left, large distal radial component, x-small, small, medium, and large, ReMotion Right, distal radial component, x-small, small, medium, and large.", "code_info": "all item numbers and lot numbers.", "firm_fei_number": "3003640913", "recalling_firm": "Small Bone Innovations, Inc.", "address_1": "1711 S Pennsylvania Ave", "city": "Morrisville", "state": "PA", "postal_code": "19067-2507", "additional_info_contact": "Customer Support\n215-428-1791", "reason_for_recall": "The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.", "root_cause_description": "Packaging change control", "action": "Email correspondence and a notification letter, dated September 6, 2013, were sent to users requesting the immediate return of affected devices. Another notification letter, dated December 20, 2013 was also sent for recall of the additional devices after the recall was expanded.", "product_quantity": "2036 devices", "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of Canada and Mexico.", "openfda": { "k_number": [ "K131845", "K260624", "K132735", "K051385", "K944507", "K041858", "K992220", "K172688", "K032806", "K183618", "K984290", "K040611", "K213563", "K032686", "K012551", "K030384", "K060731", "K023604", "K233592", "K192754", "K994041", "K982288", "K030237", "K001385", "K231188", "K002644", "K062898", "K112030", "K885146", "K991915", "K000658", "K092721", "K011819", "K212872" ], "registration_number": [ "3010331645", "3018094310", "3014302784", "3002807310", "1222928", "1649518", "3015542154", "1450662", "3007993775", "3011580264", "3000931034", "3010120148", "2027487", "3010173425", "3008337808", "3006356043", "3043543260", "2249697", "3015399803", "3002907620", "3002807295", "3033509898", "3005641619", "1828464", "1720929", "3008421730", "1824199", "3006846753", "1319429", "1226544", "2032098", "3011683674", "3020703621", "3009241418", "3010120135", "3010049501", "9611390", "3015207155", "1834331", "3004635447", "1649379", "1423662", "3010386387", "3009417901", "1043653", "3004748528", "3021008900", "1030489", "3008868758", "1834379", "3010032903", "3003761012", "2134947", "1526534", "3013176080", "1226425", "2183946", "3004464325", "2028632", "2133928", "1220246", "9610726", "3006742481", "1522875", "3015516266", "1822565", "3009959868", "3005061536", "3010041430", "3004188066", "3019767615", "3006783837", "1058084", "1825034", "1424263", "3038503932", "3010667733", "2029275", "8010379", "1835572", "2134285", "3008108789", "1649833", "1020279", "3025141", "3007366790", "3010120104", "3010178296", "3003403260", "3004142400", "3009826895", "3008812560", "3010863450", "3003477135", "8031020", "3025603301", "3036756245", "1043534", "1818910", "3035366890", "3006128100", "3034676720" ], "fei_number": [ "3010331645", "3001236277", "3003015552", "3000718490", "3018094310", "3014302784", "3002807310", "3010938185", "3007282753", "3015542154", "1450662", "3007993775", "3011580264", "3000931034", "3010120148", "1000220733", "2027487", "1000306431", "3002807172", "3008337808", "3006356043", "3043543260", "1000120314", "3015399803", "3002907620", "3002807295", "3002806773", "3033509898", "3005641619", "1828464", "1720929", "3008421730", "1824199", "3006846753", "3011683674", "3020703621", "3009241418", "3010120135", "3010049501", "1000306303", "3015207155", "3004635447", "3009322142", "1000125025", "3010386387", "3001452082", "3009417901", "1043653", "3000215273", "3004748528", "3021008900", "3003070421", "3008868758", "1000116116", "3010032903", "3003761012", "1526534", "3013176080", "3004464325", "1000306340", "1220246", "3003128516", "3006742481", "1522875", "3015516266", "3009959868", "3001584317", "1000125930", "3005061536", "3002287318", "3010041430", "3002807830", "3004188066", "3019767615", "1000120613", "1825034", "3038503932", "3003058448", "3010667733", "3008108789", "1020279", "3010120104", "3002807036", "3003403260", "3004142400", "3003018882", "1000199976", "3009826895", "1000221981", "3008812560", "3010863450", "3003477135", "3025603301", "3036756245", "3000717902", "1043534", "1000477302", "1818910", "3035366890", "3006128100", "3034676720", "3003110073" ], "device_name": "Prosthesis, Elbow, Hemi-, Radial, Polymer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3170", "device_class": "2" } } ] }