STERNALOCK® BLU SYSTEM 73-2622Recalls & reported problems
Biomet Microfixation, Inc · Class 2 · Implant
All models of STERNALOCK BLU SYSTEM (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841036141066), received between Mar 20, 2019 and Jan 8, 2020 — classified as 4 injuries.
The most frequently reported specific device problem is “Migration” (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
- Migration2
- Noise, Audible2
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
Patient problems
- Foreign Body In Patient2
- Injury1
- No Information1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT A STERNAL EMERGENT RE-ENTRY DUE TO AN UNKNOWN REASON. THE PATIENT WAS CLOSED WITH NEW PLATES AND SCREWS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Information
MAUDE report 9564290 ↗InjurySep 5, 2019Fracture; Fracture
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: Injury; No Patient Involvement
MAUDE report 8966994 ↗InjuryMar 20, 2019Noise, Audible; Migration; Noise, Audible; Migration
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: Foreign Body In Patient
MAUDE report 8437577 ↗InjuryMar 20, 2019Noise, Audible; Migration; Noise, Audible; Migration
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: Foreign Body In Patient
MAUDE report 8437576 ↗
Other PLATE, FIXATION, BONE devices
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- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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