AML EXCEL 2001-46-000Recalls & reported problems
Depuy Orthopaedics, Inc. · AML EXCEL CALCAR MILL HANDLE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295079996), received between Jul 30, 2021 and Jan 27, 2026 — classified as 2 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
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Break
IT WAS REPORTED THAT THE CALCAR PLANER SHAFT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189450 ↗MalfunctionJul 30, 2021Break; Unintended Movement; Break; Unintended Movement
IT WAS REPORTED THAT THE CALCAR REAMER SHAFT IS MISSING A WASHER WHERE IT CONNECTS TO THE DISC. AS A RESULT, THE REAMER WOBBLES ON THE CALCAR. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12252218 ↗
Other Bone mill devices
- AML EXCEL 2001-48-000Depuy (Ireland) · Bone mill472 reports
- AML EXCEL 2001-47-000Depuy (Ireland) · Bone mill220 reports
- AML EXCEL 2001-49-000Depuy (Ireland) · Bone mill212 reports
- SUMMIT 2570-04-100Depuy (Ireland) · Bone mill193 reports
- SUMMIT 2570-04-200Depuy (Ireland) · Bone mill91 reports
- NA L94010Depuy (Ireland) · Bone mill22 reports
- LPS 2987-70-001Depuy (Ireland) · Bone mill5 reports
- NA 4861-00-010Depuy (Ireland) · Bone mill4 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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