RIBFIX BLU SYSTEMRecalls & reported problems across all models
Biomet Microfixation, Inc · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 56
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls
- 0
We found 19 models of RIBFIX BLU SYSTEM by Biomet Microfixation, Inc in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Mar 18, 2019 and Jan 9, 2025 — classified as 52 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (29 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported RIBFIX BLU SYSTEM problems
Device problems
- Fracture29
- Loosening of Implant Not Related to Bone-Ingrowth14
- Migration or Expulsion of Device5
- Physical Resistance/Sticking4
- Adverse Event Without Identified Device or Use Problem3
- Defective Device1
- Migration1
Patient problems
- Failure of Implant28
- Bone Fracture(s)14
- Pain5
- Discomfort4
- No Information4
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient3
- Impaired Healing2
RIBFIX BLU SYSTEM models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RIBFIX BLU SYSTEM 76-2412Screw, fixation, bone10 reports
- RIBFIX BLU SYSTEM 76-2602PLATE, FIXATION, BONE6 reports
- RIBFIX BLU SYSTEM 76-2601Plate, fixation, bone5 reports
- RIBFIX BLU SYSTEM 76-2410PLATE, FIXATION, BONE4 reports
- RIBFIX BLU SYSTEM 76-0017Plate, fixation, bone4 reports
- RIBFIX BLU SYSTEM 76-2408Plate, fixation, bone4 reports
- RIBFIX BLU SYSTEM 76-2603Plate, fixation, bone4 reports
- RIBFIX BLU SYSTEM 76-2601PLATE, FIXATION, BONE3 reports
- RIBFIX BLU SYSTEM 76-2603PLATE, FIXATION, BONE3 reports
- RIBFIX BLU SYSTEM 76-2412Screw, fixation, bone2 reports
- RIBFIX BLU SYSTEM 76-2604PLATE, FIXATION, BONE2 reports
- RIBFIX BLU SYSTEM 76-2602Plate, fixation, bone2 reports
- RIBFIX BLU SYSTEM 76-2408PLATE, FIXATION, BONE1 report
- RIBFIX BLU SYSTEM 76-2712PLATE, FIXATION, BONE1 report
- RIBFIX BLU SYSTEM 76-2412-5PKScrew, fixation, bone1 report
- RIBFIX BLU SYSTEM 76-2414-5PKPLATE, FIXATION, BONE1 report
- RIBFIX BLU SYSTEM 76-0035Screw, fixation, bone1 report
- RIBFIX BLU SYSTEM 76-0036SCREWDRIVER1 report
- RIBFIX BLU SYSTEM 76-2410Screw, fixation, bone1 report
Recent RIBFIX BLU SYSTEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 9, 2025Fracture; Fracture
IT WAS REPORTED THAT PRODUCT FRACTURED INSIDE THE PATIENT DURING THE POST-OPERATIVE PERIOD 2 MONTHS AFTER SURGERY. THE PATIENT WAS REVISED.
Patient problems: Insufficient Information
MAUDE report 21118521 ↗InjuryDec 31, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21048109 ↗InjuryDec 31, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21048107 ↗InjuryDec 31, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21048105 ↗InjuryDec 31, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21048073 ↗InjuryDec 31, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21048052 ↗InjuryDec 31, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21048051 ↗InjuryDec 31, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21047975 ↗InjuryDec 31, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21047972 ↗InjuryDec 31, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21047968 ↗InjuryDec 31, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21047902 ↗InjuryDec 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21043563 ↗InjuryDec 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 20834244 ↗InjuryDec 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 20834225 ↗InjuryDec 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 20834207 ↗
Other Biomet Microfixation, Inc products
- TMJ SYSTEM36 models · 458 reports
- "1.5MM" SYSTEM35 models · 224 reports
- STERNALOCK BLU SYSTEM31 models · 122 reports
- 2.0 LACTOSORB SYSTEM16 models · 110 reports
- TRAUMAONE SYSTEM39 models · 80 reports
- 2.4MM SYSTEM7 models · 70 reports
- PECTUS SYSTEM35 models · 55 reports
- STERNALOCK 360 SYSTEM3 models · 51 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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