DeviceSignal · Recall classified
restor3d Inc.
FDA classified a device recall on 2026-08-19 · Class II · Z-2987-2026
EventRecall classified
Effective2026-08-19
ClassificationClass II
On 2026-08-19 the FDA classified a device recall from restor3d Inc. as Class II. Product: Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard…. Recall Z-2987-2026. The firm initiated it on 2026-06-30. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2987-2026
- Classification
- Class II
- Classified on
- 2026-08-19
- Initiated on
- 2026-06-30
- Firm
- restor3d Inc.
- Reason
- Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
- 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
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2987-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
915c9ee98600114628c723fa8a787a9d3ab4e14403c34660dd54569ed77acf2d- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)