AUGMENT® Injectable K30001510Recalls & reported problems
Biomimetic Therapeutics, LLC · Injectable Kit · Class 3 · Implant
Data updated Oct 16, 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 10859477002133), received between Jan 18, 2023 and Jan 18, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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 16, 2026.
Most reported problems
Device problems
- Component Missing1
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.
MalfunctionJan 18, 2023Component Missing; Component Missing
IT WAS REPORTED THAT THE 1.5 CC LIQUID VIAL WAS MISSING FROM THE KIT. ANOTHER COMPANIES INJECTABLE WAS USED TO COMPLETE THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16194799 ↗
Other Filler, Bone Void, Synthetic Peptide devices
- i-FACTOR Peptide Enhanced Bone Graft 700-010Cerapedics Inc. · Filler, Bone Void, Synthetic Peptide1 recall3 reports
- PearlMatrix P-15 Peptide Enhanced Bone Graft, 1.0cc 730-010Cerapedics Inc. · Filler, Bone Void, Synthetic Peptide1 recall0 reports
- AUGMENT® Injectable K30003010Biomimetic Therapeutics, LLC · Filler, Bone Void, Synthetic Peptide7 reports
- i-FACTOR™ Peptide Enhanced Bone Graft 700-050Cerapedics Inc. · Filler, Bone Void, Synthetic Peptide4 reports
- i-FACTOR™ Peptide Enhanced Bone Graft 700-050Cerapedics Inc. · Filler, Bone Void, Synthetic Peptide1 report
- i-FACTOR Peptide Enhanced Bone Graft 700-025Cerapedics Inc. · Filler, Bone Void, Synthetic Peptide1 report
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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