NA 00-8851-002-03Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024376113), received between Apr 7, 2022 and Sep 25, 2024 — classified as 3 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
- Intermittent Loss of Power1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2024Gas/Air Leak; Gas/Air Leak
NO ADDITIONAL EVENT INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20299936 ↗MalfunctionOct 5, 2023Gas/Air Leak; Gas/Air Leak
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17875707 ↗MalfunctionApr 7, 2022Gas/Air Leak; Intermittent Loss of Power; Gas/Air Leak; Intermittent Loss of Power
IT WAS REPORTED THAT AFTER LAYING THE SURGICAL FIELD THE INSTRUMENT ENGINE HOSE HAD A LEAK, WHICH CONSEQUENTLY CAUSED LOSS OF POWER TO THE DEVICE. THE PROCEDURE WAS COMPLETED WITH THE DEVICE. THERE WAS AN UNKNOWN DELAY IN PROCEDURE DUE TO THE LOSS OF POWER. THERE WAS NO HARM REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14042345 ↗
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
- Air Dermatome 00-8801-002-00Zimmer Orthopaedic Surgical Products, Inc. · Dermatome5 reports
- NA 00-8851-002-05Zimmer 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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