MicroAire® 23202Recalls & reported problems
Microaire Surgical Instruments 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 00847399006882), received between Jul 8, 2020 and Feb 11, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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
- Deformation Due to Compressive Stress1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
THE CUSTOMER STATED THAT ONE (1) OF THE ULTRATINE (CFD-23202 LOT # 360045) BROKE UPON INSERTION. THEY WERE ABLE TO USE A REPLACEMENT (CFD-23202 LOT # 348147) TO SUCCESSFULLY COMPLETE THE SURGERY. DUE TO THE INITIAL IMPLANT BREAKING THIS CAUSED A ONE (1) HOUR DELAY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13514745 ↗MalfunctionJul 8, 2020Device Dislodged or Dislocated
A CUSTOMER HAS REPORTED THAT A PATIENT WAS IMPLANTED WITH ULTRATINE IN (B)(6) 2020. THE PATIENT LATER CONTACTED THE SURGEON TO REPORT THAT THE DEVICE HAD STARTED TO DISLODGE FROM THE HOLE DRILLED FOR IT. A SUBSEQUENT APPOINTMENT HAS BEEN SCHEDULED FOR A POSSIBLE REVISION SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10247346 ↗
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- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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