{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "205077", "product_res_number": "Z-0726-2024", "event_date_initiated": "2023-08-29", "event_date_posted": "2024-01-12", "recall_status": "Open, Classified", "res_event_number": "93668", "product_code": "MBF", "k_numbers": [ "K222427" ], "product_description": "PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code:\nBASEPLATE D.25MM REGULAR/1975.14.500,\nBASEPLATE D.28MM REGULAR/1975.14.800,\nBASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510,\nBASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810,\nBASEPLATE D.25MM FULL WEDGED 15-degrees/1975.14.615,\nBASEPLATE D.28MM FULL WEDGED 15-degrees/1975.14.815,\nBASEPLATE D.28MM FULL WEDGED 15-degrees X/1975.14.865,\nBASEPLATE D.25 MM FULL WEDGED 20-degrees/1975.14.620,\nBASEPLATE D.28 MM FULL WEDGED 20-degrees/1975.14.820,\nBASEPLATE D.28 MM FULL WEDGED 20-degrees X/1975.14.870", "code_info": "Product Code/UDI-DI:\n1975.14.500/08033390244824,\n1975.14.800/08033390244893,\n1975.14.510/08033390231299,\n1975.14.810/08033390244909,\n1975.14.615/08033390244848,\n1975.14.815/08033390244916,\n1975.14.865/08033390244930,\n1975.14.620/08033390231312,\n1975.14.820/08033390244923,\n1975.14.870/08033390244947", "firm_fei_number": "3008021110", "recalling_firm": "Limacorporate S.p.A", "address_1": "Via Nazionale 52 52 Di San Daniele", "city": "San Daniele Del Friuli", "country": "Italy", "additional_info_contact": "Roberto Gabetta\n+390432945511", "reason_for_recall": "Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position.", "root_cause_description": "Device Design", "action": "On 8/29/23, the firm phoned all agents and surgeons to immediately stop surgeries with affected devices. On 10/10/23 the firm emailed recall notices to customers asking them to take the following actions:\n\n1) Surgeons are suggested to perform a short-term patient s monitoring (radiographs at 6 weeks, 3-6 months and 1 year might be considered) and acting accordingly, based on a case-by-case evaluation.\n2) Locate, quarantine, and return affected devices.\nComplete and return the response form to uscomplaint@limacorporate.com\n3) Customers with questions can email the firm at medicalcomplaints@limacorporate.com", "product_quantity": "179", "distribution_pattern": "US: IL, MO, CA, IN, MI, OK", "openfda": { "k_number": [ "K253592", "K123297", "K193038", "K010635", "K163397", "K011047", "K060716", "K233712", "K223876", "K220792", "K844415", "K240876", "K070565", "K162068", "K081448", "K250848", "K032895", "K231516", "K191963", "K130126", "K231099", "K251098", "K083439", "K060692", "K201905", "K222427", "K230831", "K063652", "K202716", "K213856", "K140390", "K043100", "K173824", "K112905", "K183553", "K212933", "K011099" ], "device_name": "Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3670", "device_class": "2", "registration_number": [ "8010916", "2029275", "1822565", "3015806723", "1828288", "3013055499", "1423662", "3015916578", "1644408", "3009417901", "3015542154", "3006946276", "3010178296", "3010386387", "1825034", "3011461101", "8043792", "3009475821", "3007923096", "3014315560", "3017397663", "3011274144", "1220246", "1836116", "3007993775", "3016851379", "3008421730", "3014680795", "9681465", "3002579136", "3008812251", "1064858", "3008868758", "3015231789", "3004748528", "3014302784", "3008534770", "1450662", "1000517406", "3008812560", "3012725451", "3009887475", "1422572", "1835831", "3010009693", "3026771806", "3006128100", "3008791302", "9617840", "3009546990", "3011015572", "1526534", "8010379", "1221934", "3008021110", "3004976965", "3012319330", "2183946", "1834331", "1835444", "3004641308", "3011683674", "9616944", "3012544635", "3020967480", "3008395353", "3006801265", "3002806470", "1721676", "1424263", "3010331645", "1834379", "3027484613", "9616671", "3005180920", "3021008900", "1818910", "1529009", "3010057495", "3015399803", "3010163695", "1000200989", "3004153896", "3007740680", "3005497913", "3008110533", "3010173425", "3013176080", "3035366890", "3002806603", "3003898228", "3006017180", "2528981", "3015207155", "3015516266", "3003403260", "3013791180" ], "fei_number": [ "1000116116", "3015806723", "1828288", "3002808293", "3013055499", "3015916578", "3009417901", "1000199976", "3015542154", "3006946276", "3010386387", "1000220336", "1825034", "3011461101", "3002854251", "1000149660", "3009475821", "3007923096", "3002807036", "3014315560", "3017397663", "1000306340", "3011274144", "1220246", "3007993775", "3003569173", "3016851379", "3008421730", "3003110073", "1000220733", "3014680795", "3008397795", "1000306431", "3002579136", "3008868758", "3015231789", "3004748528", "1000306303", "3014302784", "3008534770", "1450662", "1000517406", "3008812560", "3012725451", "3003414678", "3009887475", "3010009693", "3026771806", "3006128100", "3008791302", "3009546990", "3011015572", "3002808269", "1000116912", "1526534", "3003714383", "1221934", "3008021110", "3004976965", "3012319330", "3004641308", "3001814066", "3011683674", "3012544635", "3020967480", "3002687954", "3008395353", "3006801265", "3002806470", "1721676", "3000215273", "3010331645", "3027484613", "3005180920", "3021008900", "1818910", "3010057495", "3015399803", "3010163695", "1000200989", "3004153896", "3007740680", "3005497913", "3008110533", "3003015552", "3002807113", "3013176080", "3035366890", "3002806603", "3003898228", "3006017180", "2528981", "3015207155", "3015516266", "3000717687", "3003403260", "3013791180" ] } } ] }