Air Dermatome 00-8801-002-00Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · Dermatome Hose · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024375918), received between Nov 30, 2022 and Dec 19, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak3
- Excess Flow or Over-Infusion1
- Fitting Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
IT WAS REPORTED THAT THE HOSE IS CONTINUALLY BLOWING AIR. THERE IS NO INFORMATION PROVIDED REGARDING THE TIMING OF THE EVENT OR IF THERE WAS ANY PATIENT INVOLVEMENT/HARM THAT MAY HAVE OCCURRED. DURING DEVICE EVALUATION, IT WAS DISCOVERED THAT THERE WAS A LEAK WHERE THE HOSE CONNECTS TO THE AIR SUPPLY. DUE DILIGENCE IS COMPLETE; THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 23850312 ↗MalfunctionDec 11, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT DURING SURGERY THE DEVICE EXHIBITED LOW PRESSURE ACCOMPANIED BY A LEAKING SOUND. THE HOSE WAS CONFIRMED TO BE WHERE THE LEAKING WAS COMING FORM. NO PATIENT IMPACT WAS NOTED. DILIGENCE IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23783506 ↗MalfunctionFeb 26, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE HOSE FROM A DERMATOME HAD A LEAK. THERE WAS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 21472900 ↗MalfunctionOct 2, 2023Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT DURING SURGERY THAT THE UNIT HAS AN AUDIBLE SOUND OF AIR AT THE CONNECTION. THERE WAS NO HARM, INJURY OR DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.NO ADVERSE EVENT REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17855674 ↗MalfunctionNov 30, 2022Fitting Problem; Fitting Problem
NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15889039 ↗
Other Dermatome devices
- Dermatome 00-8801-001-00Zimmer Orthopaedic Surgical Products, Inc. · Dermatome1 recall631 reports
- Dermatome 00-8821-001-00Zimmer Orthopaedic Surgical Products, Inc. · Dermatome614 reports
- Dermatome 88710100Zimmer Orthopaedic Surgical Products, Inc. · DERMATOME242 reports
- Dermatome 00-8800-000-10Zimmer Orthopaedic Surgical Products, Inc. · Dermatome1 recall109 reports
- NA 00-8851-002-06Zimmer Orthopaedic Surgical Products, Inc. · DERMATOME22 reports
- ACCULAN 3TI GA670Aesculap AG · Dermatome6 reports
- NA 00-8851-002-05Zimmer Orthopaedic Surgical Products, Inc. · DERMATOME3 reports
- NA 00-8851-002-03Zimmer Orthopaedic Surgical Products, Inc. · DERMATOME3 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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