Calcibon 4011630001Recalls & reported problems
Biomet Biologics, LLC · Class 2 · Implant
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 07350023774307), received between Apr 30, 2019 and Apr 30, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Improper Chemical Reaction” (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.
Most reported problems
Device problems
- Improper Chemical Reaction2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2019Improper Chemical Reaction; Improper Chemical Reaction
IT HAS BEEN REPORTED THAT THE CEMENT WAS NOT SOLIDIFIED FOR 30 MINUTES DURING THE SURGERY. THE EVENT OCCURED ON TWO CEMENTS OF SAME REFERENCE AND SAME BATCH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8563987 ↗MalfunctionApr 30, 2019Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED THAT THE CEMENT WAS NOT SOLIDIFIED AFTER MIXING IT UP DURING THE SURGERY. (IT WAS SOLIDIFIED 2 HOURS LATER.)
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8563905 ↗
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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