{ "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": "221495", "product_res_number": "Z-2987-2026", "event_date_initiated": "2026-06-30", "event_date_posted": "2026-08-19", "recall_status": "Open, Classified", "res_event_number": "99402", "product_code": "PHX", "k_numbers": [ "K243643" ], "product_description": "Brand Name: Veritas Standard Reverse Total Shoulder\nProduct Name: Veritas Standard Glenoid Baseplate\nModel/Catalog Number: 1500-1030; 1500-1035\nSoftware Version: N/A - off-the-shelf hardware product\nProduct Description: The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse \nshoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The \nrestor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere \nintraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the \nhumeral stem. Additionally, the system includes supporting standard instrument trays and all required \naccessories (e.g., security screws, peripheral screws). The restor3d rTSA System is indicated for use in \npatients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously \nfailed shoulder joint replacement with a grossly deficient rotator cuff.\n\nThe Veritas standard glenoid baseplate is the only component within scope of this field action. The patient-specific baseplate is unaffected by this defect and therefore not in scope.\nComponent: Reverse Total Shoulder", "code_info": "Lot Code: Model No 1500-1030; UDI-DI 00840097513225; Lot Numbers A00030, A00065, A09828, A09830 \n\nModel No 1500-1035; UDI-DI 00840097513232; Lot Numbers A00064, A09829", "firm_fei_number": "3014833750", "recalling_firm": "restor3d Inc.", "address_1": "4001 E Nc 54 Hwy", "address_2": "Suite 3160", "city": "Durham", "state": "NC", "postal_code": "27709", "additional_info_contact": "Brianna Gabbard\n1-786-5210501", "reason_for_recall": "Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.", "root_cause_description": "Device Design", "action": "On 06/30/2027 and 07/02/2026, emailed an \"URGENT: MEDICAL DEVICE VOLUNTARY RECALL\" Letter informing customers that, restor3d has identified a machining nonconformance affecting the peripheral screw holes on certain Veritas standard glenoid baseplates.\n\nCustomers are instructed to:\nImmediately upon receipt of this notice:\n.Do not implant or otherwise use any affected units identified above.\n.Quarantine all affected, unused units identified above and remove them from implant sets, consignment inventory, inventory shelves, and any other storage locations.\n. Complete the attached Field Action Response Form (Attachment A) and return it to restor3d within 10 business days, whether or not affected product is in your possession, so that restor3d can confirm effective distribution of this notice.\n. Package the affected Veritas standard glenoid baseplates (1500-1030 and 1500-1035) to return to restor3d. restor3d has provided a prepaid FedEx shipping label by email for shipment back to 4001 NC-54 Hwy, Suite 2160 Durham, NC 27709.\n. Promptly report to restor3d any intraoperative issue, patient adverse event, suspected device related complication, loosening, migration, revision surgery, or other clinical concern potentially associated with the affected product.", "product_quantity": "59", "distribution_pattern": "U.S. Nationwide distribution in the state of Texas.", "openfda": { "k_number": [ "K173717", "K180632", "K100142", "K133378", "K130661", "K120739", "K071948", "K073676", "K253624", "K172767", "K093275", "K261683", "K260583", "K050315", "K241043", "K092900", "K150488", "K111735", "K081059", "K193372", "K130895", "K062116", "K073688", "K161742", "K222936", "K093803", "K243448", "K152754", "K193394", "K122442", "K063569", "K150458", "K170711", "K120374", "K250644", "K202098", "K211074", "K113523", "K210207", "K030941", "K240278", "K163669", "K211553", "K172502", "K243826", "K223211", "K101996", "K203375", "K234105", "K102951", "K202024", "K061439", "K252788", "K140082", "K173900", "K183696", "K162726", 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"2" } } ] }