Recalling firm: restor3d Inc.
Device class: 2
Device name: Shoulder Prosthesis, Reverse Configuration
Event initiated: 2026-06-30
FDA posted: 2026-08-19
Recall ID: Z-2987-2026
Product: 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
Reason for recall
Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.