NA 00-8851-002-05Recalls & 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 00889024376137), received between Mar 20, 2024 and Nov 26, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak2
- Fitting Problem1
- Material Integrity Problem1
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.
MalfunctionNov 26, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED DURING SURGERY THAT THE HOSE HAS A LEAK AT THE END THAT CONNECTS TO THE WALL/AIR OUTLET. THERE IS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20778273 ↗MalfunctionNov 5, 2024Fitting Problem; Fitting Problem
IT WAS REPORTED THAT DURING RECEIVING INSPECTION, ONE AIR HOSE WILL NOT CONNECT TO THE DERMATOME BUT TWO OTHERS ARE FUNCTIONAL. THERE WAS NO PATIENT INVOLVEMENT OR IMPACT. DUE DILIGENCE INFORMATION COMPLETE AS NO ADDITIONAL INFORMATION INDICATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20609857 ↗MalfunctionMar 20, 2024Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem
NO ADDITIONAL EVENT INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18940097 ↗
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 00-8851-002-03Zimmer 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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