AEQUALIS™ FLEX REVIVE™ ARS742502Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00846832068821), received between Apr 11, 2024 and Mar 20, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Fracture2
- Crack1
- Material Deformation1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2026Crack
THE SCREW INSIDE THE TRIAL HAS CRACKED AND WILL NOT TIGHTEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24655191 ↗MalfunctionJun 10, 2024Break; Fracture; Break; Fracture
INSIDE PARTS ARE BROKEN, CAN NO LONGER LOWER RETAINING PIN. THIS WAS FOUND DURING SET INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19500871 ↗MalfunctionMay 24, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE TRIAL IS BROKEN. NO IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19397572 ↗MalfunctionApr 11, 2024Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation
AS REPORTED: "STRIPPED THREADS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19087492 ↗
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- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
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- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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