Notice names this product. restor3d’s Brand Name is named in FDA Class II recall Z-2987-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws. Identifying details: Lot 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. Units affected: 59. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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 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
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
Company / brand: restor3d recalls
Affected product: Brand Name recall status
Official ID Z-2987-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.