AEQUALIS™ FLEX REVIVE™ ARS742503Recalls & reported problems
Tornier, Inc. · Class 2
All models of AEQUALIS FLEX REVIVE (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00846832068838), received between Jun 11, 2025 and Nov 20, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (2 reports).
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
- Mechanical Problem2
- Break1
- Device Difficult to Setup or Prepare1
- Failure to Clean Adequately1
- Fracture1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THAT PRODUCT WAS NOT POSSIBLE TO CLEAN THE COMPLETE INSIDE OF THE INSTRUMENT DURING THE STERILIZATION PROCESS. THE STAFF REPORTED THAT THEY CUT THE DEVICE INTO TWO PIECES TO CHECK IF IT WAS 100% CLEAN. THIS WAS DONE WITHOUT ANY CONFIRMATION FROM STRYKER. DURING THE CLEANING PROCESS, WE ARE NOT 100% SURE IF THE STAFF FOLLOWED THE IFU CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23605196 ↗MalfunctionOct 7, 2025Positioning Failure; Mechanical Problem; Positioning Failure; Mechanical Problem
IT WAS REPORTED THAT THE SET SCREW ON THE SIZE 13 REVIVE PROXIMAL BODY TRIAL DID NOT PROPERLY ENGAGE WITH THE DISTAL STEM. THE CAUSE OF THE ISSUE IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23233868 ↗MalfunctionJul 8, 2025Mechanical Problem; Mechanical Problem
WHILE INSPECTING THE PROXY BODY, IT WAS NOTICED THAT IT NO LONGER LOCKED IN THE STEM CORRECTLY AND NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22440464 ↗MalfunctionJun 12, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE SCREW INSIDE THE PROXIMAL BODY SPLIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22194620 ↗MalfunctionJun 11, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
IT WAS REPORTED THAT THE TRIAL IS UNABLE TO COMPLETELY SCREW DOWN DURING INBOUND INSPECTION POST CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22185506 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 reports
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.
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