Humelock Reversed Shoulder 903-0102Recalls & reported problems
Fx Solutions · HUMELOCK REVERSED T HANDLE / AO · Class 1
All models of Humelock Reversed Shoulder (13)
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 03701037306185), received between May 14, 2024 and May 14, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
WHEN CHECKING THE INSTRUMENTATION INTO THE HOSPITAL FOR A CASE ON (B)(6) 2024, THE STERILIZATION OFFICER PULLED TWO T HANDLES FROM THE KIT FOR CONTAMINATION. THE STERILIZATION OFFICER BELIEVED THE CONTAMINANT TO BE BLOOD OR BIOBURDEN. BASED ON A REVIEW OF PROVIDED PHOTOS, THE CONTAMINANT IS LIKELY RUST. REGARDLESS, THE PARTS WERE CLEANED TO THE HOSPITAL'S STANDARDS BEFORE CHECK IN WAS FINALIZED. NO SURGICAL DELAY OCCURRED AS THE CASE THE INSTRUMENTATION WAS FOR HAD ALREADY BEEN RESCHEDULED FOR UNRELATED REASONS. CAPA-2024-0027 HAS BEEN OPENED TO ADDRESS THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19315591 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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