Aequalis Reversed II MWB197Recalls & reported problems
Tornier · Humeral Impactor/Extractor · Class 1
All models of AEQUALIS REVERSED II (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700386969287), received between Mar 29, 2018 and Mar 29, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Naturally Worn” (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
- Naturally Worn1
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.
MalfunctionMar 29, 2018Naturally Worn; Naturally Worn
THE HUMERAL IMPACTOR WAS BEING USED TO ASSEMBLE THE FINAL STEM AND METAPHYSEAL IMPLANTS FOR THE REVERSE II. THE IMPACTOR APPEARED TO HOLD INITIALLY, BUT WHEN ANY TORQUE WAS APPLIED TO IT, IT WOULD DETACH FROM THE METAPHYSEAL IMPLANT. THIS RESULTED IN THE CONSULTANT BEING UNSURE AS TO WHETHER THE IMPLANTS WERE SECURELY ASSEMBLED. ALL APPROPRIATE TECHNIQUE STEPS WERE FOLLOWED. WE BELIEVE IT MAY BE THE THREAD ON THE HUMERAL IMPACTOR FIXATION SCREW BEING WORN. THE HUMERAL EXTRACTOR (PART# MWB498) WAS USED INSTEAD OF THE HUMERAL IMPACTOR (PART#MWB197) AND THE SURGERY WAS EXTENDED BY APPROXIMATELY 30 MINS DUE TO THIS ISSUE.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7381169 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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