Veritas rTSARecalls & reported problems across all models
Restor3d, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Veritas rTSA model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 1
We found 7 models of Veritas rTSA by Restor3d, Inc. in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Apr 17, 2026 and Sep 30, 2026 — classified as 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Veritas rTSA recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 30, 2026Open, Classified
Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
Z-2987-2026 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
Most reported Veritas rTSA problems
Device problems
- Device Dislodged or Dislocated4
- Adverse Event Without Identified Device or Use Problem1
- Migration1
- No Apparent Adverse Event1
Patient problems
- Joint Dislocation6
- No Clinical Signs, Symptoms or Conditions1
Veritas rTSA models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Veritas rTSA 1500-1030Shoulder Prosthesis, Reverse Configuration1 recall1 report
- Veritas rTSA 1500-1035Shoulder Prosthesis, Reverse Configuration1 recall0 reports
- Veritas rTSA 3500-140C3Shoulder Prosthesis, Reverse Configuration2 reports
- Veritas rTSA 3500-140U1Shoulder Prosthesis, Reverse Configuration1 report
- Veritas rTSA 3500-140C1Shoulder Prosthesis, Reverse Configuration1 report
- Veritas rTSA 3500-340U1Shoulder Prosthesis, Reverse Configuration1 report
- Veritas rTSA 3500-536U3Shoulder Prosthesis, Reverse Configuration1 report
Recent Veritas rTSA adverse event reports
The 7 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation
MAUDE report 50954585 ↗InjurySep 30, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation
MAUDE report 50954577 ↗InjurySep 10, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation
MAUDE report 50724468 ↗InjuryJul 29, 2026Migration
A patient who had received a custom proximal humerus reconstruction reported experiencing a dislocation during physical therapy. The physician was not able to perform a closed reduction of the shoulder, so performed a surgery to correct it. It was discovered intraoperatively that the locking mechanism of the polymer liner had been damaged and had disassociated from the humeral implant. A new liner was implanted.
Patient problems: Joint Dislocation
MAUDE report 50072912 ↗MalfunctionJul 10, 2026No Apparent Adverse Event
THE SURGEON USED A COMPRESSION SCRWE WITH THE STANDARD VERITAS BASEPLATE. WHILE COMPLETING FINAL TORQUE, THE COMPRESSION SCREW PUSHED THROUGH THE BASEPLATE. THE SALES REPRESENTATIVE NOTED THAT THE WEEK PRIOR THERE WAS A BASEPLATE THAT HAS A COMPRESSION SCREW SEAT LOWER THAN EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25778977 ↗InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISLOCATION OF THE SHOULDER APPROXIMATELY 3 DAYS AFTER SHOULDER REPLACEMENT WITH PROXIMAL HUMERUS RECONSTRUCTION. A REVISION SURGERY TOOK PLACE TO IMPLANT A LARGER SIZE OF GLENOSPHERE TO IMPROVE SOFT TISSUE TENSION AND WAS SUCCESSFUL, THOUGH IT WAS NOTED THERE WAS DIFFICULTY ENGAGING THE POLY BEARING TO THE HUMERAL IMPLANT. THE PATIENT DISLOCATED ONCE AGAIN SEVERAL DAYS LATER. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.
Patient problems: Joint Dislocation
MAUDE report 25116587 ↗InjuryApr 17, 2026Device Dislodged or Dislocated
THE PATIENT RETURNED APPROXIMATELY 3 WEEKS FOLLOWING SURGERY WITH DISLOCATION OF THE SHOULDER. THE SURGEON REVISED THE PATIENT THE FOLLOWING WEEK AND CONFIRMED THE POLY WAS DISSOCIATED FROM THE PROXIMAL HUMERAL STEM.
Patient problems: Joint Dislocation
MAUDE report 24911653 ↗
Other Restor3d, Inc. products
All Restor3d, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page