Universal 2™ Total Wrist System 261301Recalls & reported problems
Ascension Orthopedics, Inc. · The Universal 2 Total Wrist carpal component is a titanium ‘plate’ which is fixed into the carpal bones with a cemented central peg and two titanium screws. · Class 2 · Implant
Data updated Oct 18, 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 10381780065913), received between May 7, 2022 and May 7, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Biocompatibility” (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 18, 2026.
Most reported problems
Device problems
- Biocompatibility1
- Fracture1
Patient problems
- Failure of Implant1
- Metal Related Pathology1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2022Fracture; Biocompatibility; Fracture; Biocompatibility
IT WAS REPORTED THAT, DURING REMOVAL, IT WAS DISCOVERED THAT THE RADIAL IMPLANT. MEDIUM. RIGHT WAS BROKEN IN THE PATIENT'S WRIST. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Failure of Implant; Metal Related Pathology
MAUDE report 14331921 ↗
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
- KinematX 137-30002-SExtremity Medical, LLC · 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
- Universal2 Total Wrist Implant System 262300Smith & Nephew, Inc. · 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
- MAESTRO TOTAL WRIST 180151Biomet Orthopedics, LLC · PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED1 report
- KinematX 137-50012-SExtremity Medical, LLC · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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