Restor3d Inc.: Shoulder Prosthesis, Reverse Configuration
Recall Summary Restor3d Inc. is recalling the Veritas Standard Glenoid Baseplate (models 1500-1030 and 1500-1035) used in reverse shoulder replacement surgery due to incorrect machining of screw holes that could prevent screws from fitting properly. The defective component was distributed nationwide across all U.S. states. This recall affects patients who have received this specific baseplate as part of their reverse total shoulder replacement.
- Recalling firm
- restor3d Inc.
- 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...
- Reason
- Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-30
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide distribution in the state of Texas.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/452ed211-a810-4cb3-9499-01b746428484