{"url_path":"/fda/device/recalls/Z-2987-2026","section_key":"summary","section_title":"DEVICE Recall: restor3d Inc. — Brand Name: Veritas Standard Reverse Total Shoulder  Product Name: Veritas Standard Glenoid Baseplate  Model/Catalog Number: 1500-1030; 1500-1035  Software Version: N/A - off-the-shelf hardware product  Product Description: The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse   shoulder replacement for patients with a …","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-30","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2987-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"restor3d Inc."},"word_count":247,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2987-2026\n\n**Recalling firm:** restor3d Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-30\n**Report date:** 2026-08-26\n\n## Product\nBrand Name: Veritas Standard Reverse Total Shoulder  Product Name: Veritas Standard Glenoid Baseplate  Model/Catalog Number: 1500-1030; 1500-1035  Software Version: N/A - off-the-shelf hardware product  Product Description: The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse   shoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The   restor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere   intraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the   humeral stem. Additionally, the system includes supporting standard instrument trays and all required   accessories (e.g., security screws, peripheral screws). The restor3d rTSA System is indicated for use in   patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously   failed shoulder joint replacement with a grossly deficient rotator cuff.    The 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.  Component: Reverse Total Shoulder\n\n## Reason\nDue to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.\n\n## Affected lots\nLot Code: Model No 1500-1030; UDI-DI 00840097513225; Lot Numbers A00030, A00065, A09828, A09830    Model No 1500-1035; UDI-DI 00840097513232; Lot Numbers A00064, A09829\n\n## Distribution\nU.S. Nationwide distribution in the state of Texas."}