Aequalis™ Fx2 DWK204BRecalls & reported problems
Tornier · 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 03700386956676), received between Sep 28, 2016 and Sep 28, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Disassembly” (1 report).
1 other recall cover devices cleared under the same FDA submission (K152966); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Disassembly1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2016Disassembly; Disassembly
THE SUBLUXATION/DISLOCATION IS EASILY REDUCED AND I SUSPECT THE POLY IS HINGING IN AND OUT. AFTER THE PATIENT HUMERUS WAS EXPOSED THE POLY INSERT WAS DISASSOCIATED FROM THE STEM. THIS CAUSED THE DISLOCATION. THE POLY WAS REMOVED. THE SURGEON DECIDED TO KEEP THE STEM IN THE PATIENT.
Patient problems: Patient Problem/Medical Problem
MAUDE report 5983097 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K152966. One submission often covers many models, so check the product and lot details in each record.
- Z-0699-2017 · Sep 19, 2016 · TerminatedAequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK2
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- 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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