FDA-Device2026-08-26Class IIPROCESSING DEFECT
restor3d Veritas Standard Glenoid Baseplate recalled for improper screw engagement risk
What this means
restor3d Inc. is recalling specific lots of the Veritas Standard Glenoid Baseplate used in reverse shoulder replacement surgery. A manufacturing error created incorrectly machined screw holes that may prevent peripheral screws from engaging properly during surgery. The defect affects only the standard baseplate; patient-specific baseplates are not affected.
- If you received this implant as part of shoulder replacement surgery, contact your surgeon or restor3d Inc. immediately to discuss your specific implant and lot number.
- Do not use affected implant lots (A00030, A00065, A09828, A09830 for Model 1500-1030; A00064, A09829 for Model 1500-1035) in any new procedures.
- Check implant lot numbers against the recall list before surgery if you have an upcoming reverse shoulder replacement.
The agency's original wording
Hazard
Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide distribution in the state of Texas.
Affected count
59
Manufactured in
4001 E Nc 54 Hwy, Suite 3160, Durham, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2987-2026More Restor3d recalls
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