{ "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": "211027", "product_res_number": "Z-0744-2025", "event_date_initiated": "2024-10-02", "event_date_posted": "2024-12-20", "recall_status": "Open, Classified", "res_event_number": "95732", "product_code": "JDB", "k_numbers": [ "K222807" ], "product_description": "TEMA Elbow - Axle Small REF 1590.15.010\n\nTEMA Elbow - Axle Large REF 1590.15.020\n\nTEMA Elbow System is a cemented total elbow prosthesis.", "code_info": "Product/Catalog Numbers: 1590.15.010 TEMA ELBOW - AXLE SMALL\nUDI-DI code: 08033390128865\nLot/Serial Numbers:\n23031752300054\n23177372300230\n23173852400087\n\nProduct/Catalog Number: 1590.15.020 TEMA ELBOW - AXLE LARGE\nUDI-DI code: 08033390128872\nLot/Serial Numbers:\n22276962300054\n23325482400047\n24006192400193", "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": "+390432945511", "reason_for_recall": "Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.", "root_cause_description": "Process control", "action": "On 10/02/2024, the firm notified U.S. surgeons of the recall and the two U.S. distributors were informed via email on 10/11/2024.\n\nAn updated/follow-up Recall Notification and Acknowledgement form is pending. The update/follow-up Recall Notification is informing surgeons and distributors that the firm has received a total of two similar complaints, regarding issues related to difficulty in disassembly of the axle component by using the screwdriver as per Surgical Technique. \nAccording to the internal investigation, the main concurring root causes of the problem seem to be the incomplete shot peening on the taper and the missing identification of a critical dimension (thread length).\n\nThe Recall Notification informs surgeons to use other instruments available in the Operating Room to successfully complete the surgery or, in the worst case, several parts/the entire implant (both the humeral and the ulnar components) should be removed. Surgeons are also asked to Fill out, sign, and send the following Acknowledgement and Receipt Form via email as confirmation that You have read and acknowledged the content of this document.\n\nFor questions or assistance, contact:\nContact of the Importer:\nKenneth Newman - Senior Regulatory Affairs Specialist (LimaCorporate now Enovis) /Recall Coordinator (Enovis)\nE-mail: Kenneth.Newman@enovis.com \n\nOr to the Manufacturer contact point:\nFederica Malvaso Post-Market Surveillance Lead (LimaCorporate now Enovis)\nE-mail: pms@enovis.com\n\nDistributors are instructed to:\nCheck your stock to locate and quarantine the affected devices. Devices must be sent back to:\nLima U.S.A., Inc. | 2001 NE Green Oaks Blvd. Ste.100 | Arlington, Texas 76006 | USA\n\nwithin 15 days together with a signed hard copy of the following Acknowledgement and Receipt Form.", "product_quantity": "~87 devices (U.S.)", "distribution_pattern": "U.S: FL and TX\n\nO.U.S.: N/A", "openfda": { "k_number": [ "K070787", "K820957", "K070236", "K171010", "K823473", "K880188", "K193247", "K960087", "K811451", "K100562", "K802460", "K182461", "K031218", "K102180", "K810847", "K801574", "K955099", "K060438", "K873660", "K802348", "K060038", "K972691", "K812322", "K983141", "K050848", "K011567", "K222807" ], "registration_number": [ "1020279", "1818910", "1526534", "8010379", "1226544", "2134285", "1221934", "3008021110", "3008337808", "3004983210", "3006356043", "1526350", "8031020", "1822565", "2183946", "1834331", "9681465", "3011683674", "3007740680", "3008395353", "3036756245", "3002806470", "1721676", "3000931034", "3010667733", "3025603301", "3015542154", "1649518", "3008868758", "3010178296", "3013176080", "1219655", "1825034", "2133928", "3035366890", "3004748528", "1220477", "3002806603", "1450662", "9616671", "3006017180", "1043534", "3002807295", "3015207155", "3015516266", "3011274144", "1649390", "3017397663", "3026771806", "3033509898", "3013791180" ], "fei_number": [ "1020279", "3003128516", "1000116116", "1818910", "1526534", "1221934", "3001236277", "3008021110", "3008337808", "3004983210", "3006356043", "1526350", "3003110073", "3000718467", "1000220733", "3000717902", "3011683674", "3002807830", "3007740680", "3008395353", "3036756245", "3002287318", "3002806470", "1721676", "1000199976", "3000931034", "3010667733", "3025603301", "3015542154", "3002807113", "3008868758", "3013176080", "1219655", "1825034", "3035366890", "3004748528", "3002854251", "1220477", "3002806603", "1450662", "3006017180", "1043534", "3002807295", "3015207155", "3015516266", "3011274144", "3017397663", "1000306340", "3026771806", "3033509898", "3013791180" ], "device_name": "Prosthesis, Elbow, Semi-Constrained, Cemented", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3160", "device_class": "2" } } ] }