{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221676", "product_res_number": "Z-3018-2026", "event_date_initiated": "2026-07-14", "event_date_posted": "2026-08-26", "recall_status": "Open, Classified", "res_event_number": "99498", "product_code": "MAI", "k_numbers": [ "K101100" ], "product_description": "CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable\nDriver\nREF# CFBC-5502B\n5.5mm GENESYs CrossFT Suture Anchor with\ntwo, #2 (5 metric) Hi-Fi Sutures\nSterile", "code_info": "UDI:10845854042472, Lot number 1513167", "firm_fei_number": "3001451571", "recalling_firm": "ConMed Corporation", "address_1": "525 French Rd", "city": "Utica", "state": "NY", "postal_code": "13502-5945", "additional_info_contact": "Brent Lalomia\n269-377-2187", "reason_for_recall": "Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.", "root_cause_description": "Labeling design", "action": "On July 14, 2026, Conmed Corporation issued an Urgent Medical Device Correction to affected consignees via email: Conmed Corporation asked consignees to take the following actions:\n\n1. Replace the Patient Implant Card with the corrected Patient Implant Card included with this notification.\n\n2.Retain the corrected Patient Implant Card for your records and discard the incorrect PIC to ensure accurate device traceability and recordkeeping.\n\n3. If you have provided these devices to other facilities or distributors, or you are a distributor, please forward this information as appropriate. \n\n4. Review your inventory for any of the devices listed in Table 1. We ask that you contact all departments within your facility and any other facilities within your organization that may have received affected products. \n\n5. Devices that have been implanted, please follow hospital protocols for identifying and notifying affected patients/users as appropriate. For devices that have not been implanted, please follow your hospital protocols to review and update the Patient Implant Card (PIC) records accordingly.\n\n6. If you have inventory of any of the devices listed in Table 1, please complete the medical device recall response form (Attachment I) and return acknowledgement via email to genesyscrossft2026@conmed.com\n\n7. For devices that have been implanted, please follow hospital protocols for identifying and notifying affected patients/users as appropriate. For devices that have not been implanted, please follow your hospital protocols to review and update the Patient Implant Card (PIC) records accordingly.\n\n8. If you have inventory of any of the devices listed in Table 1, please complete the medical device recall response form (Attachment I) and return acknowledgement via email to genesyscrossft2026@conmed.com", "product_quantity": "2 units", "distribution_pattern": "US Nationwide distribution in the state of TX.", "openfda": { "k_number": [ "K963369", "K183501", "K203495", "K253931", "K952687", "K170868", "K233971", "K060522", "K952471", "K221128", "K112040", "K990987", "K120078", "K180361", "K180101", "K062466", "K092898", "K002413", "K040827", "K051983", "K963396", "K200725", "K122869", "K170501", "K243467", "K070925", "K221099", "K003273", "K160804", "K140855", "K230394", "K943249", "K101459", "K222263", "K003076", "K083268", "K251309", "K141259", "K031981", "K231641", "K191242", "K000616", "K240288", "K964013", "K122228", "K960555", "K123393", "K163672", "K192441", "K984490", "K992938", "K130716", "K183506", "K093844", "K250526", "K171299", "K230892", "K162429", "K961789", "K240441", 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