Universal 2™ Total Wrist System 263200LFRecalls & reported problems
Ascension Orthopedics, Inc. · The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by means of a stem which is inserted and cemented into the radial intramedullary canal. · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780066071), received between Sep 19, 2025 and Sep 19, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration1
Patient problems
- Failure of Implant1
- Inflammation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 23102717 ↗
Other Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained devices
- KinematX 137-30001-SExtremity Medical, LLC · Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained4 reports
- REMOTION WA/C-MStryker GmbH · PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED2 reports
- REMOTION WA/R-RSStryker GmbH · PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED2 reports
- KinematX 137-30002-SExtremity Medical, LLC · Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained2 reports
- Universal2 Total Wrist Implant System 262300Smith & Nephew, Inc. · Prosthesis, wrist, 3 part metal-plastic-metal articulation, semi-constrained1 report
- Freedom Wrist Arthroplasty System 348291ESmith & Nephew, Inc. · Prosthesis, wrist, 3 part metal-plastic-metal articulation, semi-constrained1 report
- REMOTION WA/C-SStryker GmbH · PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED1 report
- Integra® Freedom Wrist Arthroplasty System 348292Ascension Orthopedics, Inc. · Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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