LCS 2267-44-000Recalls & reported problems
Depuy Orthopaedics, Inc. · LCS API FEMORAL FLATNESS GAUGE · Class 1
All models of LCS (45)
Data updated Oct 18, 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 10603295108870), received between Dec 4, 2019 and Jun 1, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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 18, 2026.
Most reported problems
Device problems
- Break4
- Crack1
- Material Discolored1
- Material Twisted/Bent1
Patient problems
- No Consequences Or Impact To Patient3
- Not Applicable1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2020Break; Crack; Material Discolored; Material Twisted/Bent; Break; Crack; Material Discolored; Material Twisted/Bent
BROKEN ATTUNE SHIMS AND LCS RULER REPORTED BY CSSD STAFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10106804 ↗MalfunctionMar 26, 2020Break; Break
ADDITIONAL INFORMATION RECEIVED THAT THE INSTRUMENT'S PLASTIC RULER JUST BROKE IN HALF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9885427 ↗MalfunctionJan 27, 2020Break; Break
FEMORAL IMPACTOR AND FLATNESS GAUGE BROKE DURING SURGERY - 10 MINUTE DELAY TO SURGERY, NO ADVERSE OUTCOMES.
Patient problems: Not Applicable
MAUDE report 9633637 ↗MalfunctionDec 4, 2019Break; Break
WHEN THE RULER WAS PULLED OUT OF THE TRAY IT SPIT IN TWO PIECES. PATIENT STATUS/ OUTCOME/ CONSEQUENCES: NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9412668 ↗
Other GAUGE, DEPTH devices
- NA 319.006Synthes GmbH · GAUGE, DEPTH899 reports
- NA 03.133.080Synthes GmbH · GAUGE, DEPTH174 reports
- NA 03.010.072Synthes GmbH · GAUGE, DEPTH133 reports
- MULTILOC 03.019.017Synthes GmbH · GAUGE, DEPTH119 reports
- NA 319.01Synthes GmbH · GAUGE, DEPTH113 reports
- NA 319.004Synthes GmbH · GAUGE, DEPTH82 reports
- QUICKSET 2274-60-000Depuy (Ireland) · GAUGE, DEPTH68 reports
- NA 319.09Synthes GmbH · GAUGE, DEPTH65 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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