MITEK CRUCIATE+ 219008Recalls & reported problems
Medos International Sàrl · MITEK CRUCIATE+ ACL/PCL Femoral Point Aimer 2-40mm Plus or Minus 13 Percent · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705025763), received between Feb 24, 2021 and Nov 11, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (3 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
- Mechanical Jam3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2022Mechanical Jam; Mechanical Jam
IT WAS REPORTED BY THE SALES REP IN THE UNITED KINGDOM THAT THE CRUCIATE+ FEMORAL POINT WAS NOT SLIDING PROPERLY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15779024 ↗MalfunctionNov 10, 2022Mechanical Jam; Mechanical Jam
IT WAS REPORTED BY THE SALES REP IN THE UNITED KINGDOM THAT THE CRUCIATE+ FEMORAL POINT WAS NOT SLIDING PROPERLY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15774340 ↗MalfunctionFeb 24, 2021Mechanical Jam; Mechanical Jam
IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE GUIDE PIECE DID NOT SLIDE WITH THE SLIDER ON THE CRUCIATE+ FEMORAL POINT DEVICE THAT THE DEVICE GOT STUCK DURING THE CASE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11373568 ↗
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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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