Dermatome 00-8800-000-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 00889024375895), received between Sep 20, 2022 and Apr 7, 2026 — classified as 59 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (95 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 5, 2023Class IIOpen, Classified

   Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately cover the area

   Z-0069-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 109 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT BEFORE SURGERY THE DERMATOME BLADE WAS NOTED TO BE BENT AND PLASTIC PART WAS FRACTURED. NO PATIENT INVOLVEMENT. DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800679 ↗
• MalfunctionOct 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23295389 ↗
• MalfunctionJul 17, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY, CUTTING THE GRAFT DOES NOT WORK PROPERLY. THERE WAS NO PATIENT HARM OR SURGICAL DELAY REPORTED. DURING DEVICE EVALUATION IT WAS DISCOVERED THAT THE BLADE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531451 ↗
• MalfunctionJun 27, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING ROUTINE HARVESTING OF A SKIN GRAFT, THE DERMATOME FAILED TO EXCISE A GRAFT EXCEPT ONLY ALONG ONE SMALL EDGE OF THE DERMATOME BLADE. A REPEAT ATTEMPT PROVED THE SAME RESULTS. THE ENTIRE DERMATOME SET (PRESSURIZED N2 TUBING, DERMATOME HEAD, BLADE, & GUARD) WERE CHANGED TO A NEW SET AND BROUGHT ONTO THE FIELD. A REPEAT ATTEMPT REVEALED THE SAME RESULTS. CONFERRING WITH A PARTNER ATTENDING IN TROUBLESHOOTING DID NOT IMPROVE THE PROBLEM. FINALLY, A NEW DERMATOME BLADE FROM A DIFFERENT LOT NUMBER (#66646709) WAS USED IN THE DEVICE AND THE DEVICE FUNCTIONED APPROPRIATELY. IT WAS ASSUMED THAT BLADES FROM LOT#66609275 ARE DEFECTIVE THOUGH OUTWARDLY NOT APPEARING ABNORMAL. ALL DERMATOME BLADES FROM THAT LOT WERE TAKEN OUT OF SERVICE. THERE WAS A SURGICAL DELAY OF AN UNKNOWN AMOUNT. THERE WAS NO PATIENT HARM. DUE DILIGENCE IS IN PROGRESS, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346587 ↗
• MalfunctionJun 27, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING ROUTINE HARVESTING OF A SKIN GRAFT, THE DERMATOME FAILED TO EXCISE A GRAFT EXCEPT ONLY ALONG ONE SMALL EDGE OF THE DERMATOME BLADE. A REPEAT ATTEMPT PROVED THE SAME RESULTS. THE ENTIRE DERMATOME SET (PRESSURIZED N2 TUBING, DERMATOME HEAD, BLADE, & GUARD) WERE CHANGED TO A NEW SET AND BROUGHT ONTO THE FIELD. A REPEAT ATTEMPT REVEALED THE SAME RESULTS. CONFERRING WITH A PARTNER ATTENDING IN TROUBLESHOOTING DID NOT IMPROVE THE PROBLEM. FINALLY, A NEW DERMATOME BLADE FROM A DIFFERENT LOT NUMBER (#66646709) WAS USED IN THE DEVICE AND THE DEVICE FUNCTIONED APPROPRIATELY. IT WAS ASSUMED THAT BLADES FROM LOT#66609275 ARE DEFECTIVE THOUGH OUTWARDLY NOT APPEARING ABNORMAL. ALL DERMATOME BLADES FROM THAT LOT WERE TAKEN OUT OF SERVICE. THERE WAS A SURGICAL DELAY OF AN UNKNOWN AMOUNT. THERE WAS NO PATIENT HARM. DUE DILIGENCE IS IN PROGRESS, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346551 ↗
• MalfunctionMay 1, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY THE DERMATOME PRODUCED A SKIN GRAFT WITH UNEVEN THICKNESS. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT OR ANY SURGICAL DELAY. NO ADDITIONAL INFORMATION AVAILABLE IS INDICATED. DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945580 ↗
• InjuryApr 28, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED DURING THE PROCEDURE THAT THERE WAS AN UNEVEN GRAFT THICKNESS. THERE IS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS IN PROGRESS AND NO ADDITIONAL INFORMATION IS AVAILABLE TILL DATE.

  Patient problems: Skin Tears; Unspecified Tissue Injury

  MAUDE report 21918372 ↗
• InjuryNov 11, 2024Failure to Cut; Patient Device Interaction Problem; Failure to Cut; Patient Device Interaction Problem

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s)

  MAUDE report 20658847 ↗
• InjurySep 13, 2024Failure to Cut; Patient Device Interaction Problem; Failure to Cut; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE BLADE WAS INADEQUATE. THE TAKEN GRAFT WAS DAMAGED AS IT WAS NOT ABLE TO TAKE IN ONE STRIP. SUTURES WERE NOT REQUIRED AT THE HARVEST SITE. THE PATIENT REQUIRED ADDITIONAL TIME UNDER ANESTHESIA AND ADDITIONAL SKIN GRAFTING WAS REQUIRED TO COMPLETE THE SURGERY. ANOTHER PRODUCT WAS NOT USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20211232 ↗
• InjurySep 12, 2024Failure to Cut; Patient Device Interaction Problem; Failure to Cut; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE BLADE WAS INADEQUATE. THE TAKEN GRAFT WAS DAMAGED AS IT WAS NOT ABLE TO TAKE IN ONE STRIP. SUTURES WERE NOT REQUIRED AT THE HARVEST SITE. THE PATIENT REQUIRED ADDITIONAL TIME UNDER ANESTHESIA AND ADDITIONAL SKIN GRAFTING WAS REQUIRED TO COMPLETE THE SURGERY. ANOTHER PRODUCT WAS NOT USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20208662 ↗
• InjurySep 12, 2024Failure to Cut; Material Deformation; Patient Device Interaction Problem; Failure to Cut; Material Deformation; Patient Device Interaction Problem

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20207559 ↗
• InjurySep 12, 2024Failure to Cut; Patient Device Interaction Problem; Failure to Cut; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE BLADE WAS INADEQUATE. THE TAKEN GRAFT WAS DAMAGED AS IT WAS NOT ABLE TO TAKE IN ONE STRIP. SUTURES WERE NOT REQUIRED AT THE HARVEST SITE. THE PATIENT REQUIRED ADDITIONAL TIME UNDER ANESTHESIA AND ADDITIONAL SKIN GRAFTING WAS REQUIRED TO COMPLETE THE SURGERY. ANOTHER PRODUCT WAS NOT USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20207553 ↗
• InjurySep 12, 2024Failure to Cut; Patient Device Interaction Problem; Failure to Cut; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE BLADE WAS INADEQUATE. THE TAKEN GRAFT WAS DAMAGED AS IT WAS NOT ABLE TO TAKE IN ONE STRIP. SUTURES WERE NOT REQUIRED AT THE HARVEST SITE. THE PATIENT REQUIRED ADDITIONAL TIME UNDER ANESTHESIA AND ADDITIONAL SKIN GRAFTING WAS REQUIRED TO COMPLETE THE SURGERY. ANOTHER PRODUCT WAS NOT USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20207390 ↗
• InjurySep 12, 2024Failure to Cut; Patient Device Interaction Problem; Failure to Cut; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE BLADE WAS INADEQUATE. THE TAKEN GRAFT WAS DAMAGED AS IT WAS NOT ABLE TO TAKE IN ONE STRIP. SUTURES WERE NOT REQUIRED AT THE HARVEST SITE. THE PATIENT REQUIRED ADDITIONAL TIME UNDER ANESTHESIA AND ADDITIONAL SKIN GRAFTING WAS REQUIRED TO COMPLETE THE SURGERY. ANOTHER PRODUCT WAS NOT USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20207193 ↗
• InjurySep 12, 2024Failure to Cut; Material Deformation; Patient Device Interaction Problem; Failure to Cut; Material Deformation; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE BLADE WAS BOWING. THE TAKEN GRAFT WAS DAMAGED AS IT WAS NOT ABLE TO TAKE IN ONE STRIP. SUTURES WERE NOT REQUIRED AT THE HARVEST SITE. THE PATIENT REQUIRED ADDITIONAL TIME UNDER ANESTHESIA AND ADDITIONAL SKIN GRAFTING WAS REQUIRED TO COMPLETE THE SURGERY. ANOTHER PRODUCT WAS NOT USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20206967 ↗
• InjurySep 12, 2024Failure to Cut; Patient Device Interaction Problem; Failure to Cut; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE BLADE WAS INADEQUATE. THE TAKEN GRAFT WAS DAMAGED AS IT WAS NOT ABLE TO TAKE IN ONE STRIP. SUTURES WERE NOT REQUIRED AT THE HARVEST SITE. THE PATIENT REQUIRED ADDITIONAL TIME UNDER ANESTHESIA AND ADDITIONAL SKIN GRAFTING WAS REQUIRED TO COMPLETE THE SURGERY. ANOTHER PRODUCT WAS NOT USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20206805 ↗
• InjurySep 12, 2024Failure to Cut; Patient Device Interaction Problem; Failure to Cut; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE BLADE WAS INADEQUATE. THE TAKEN GRAFT WAS DAMAGED AS IT WAS NOT ABLE TO TAKE IN ONE STRIP. SUTURES WERE NOT REQUIRED AT THE HARVEST SITE. THE PATIENT REQUIRED ADDITIONAL TIME UNDER ANESTHESIA AND ADDITIONAL SKIN GRAFTING WAS REQUIRED TO COMPLETE THE SURGERY. ANOTHER PRODUCT WAS NOT USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20206100 ↗
• InjurySep 12, 2024Failure to Cut; Patient Device Interaction Problem; Failure to Cut; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE BLADE WAS INADEQUATE. THE TAKEN GRAFT WAS DAMAGED AS IT WAS NOT ABLE TO TAKE IN ONE STRIP. SUTURES WERE NOT REQUIRED AT THE HARVEST SITE. THE PATIENT REQUIRED ADDITIONAL TIME UNDER ANESTHESIA AND ADDITIONAL SKIN GRAFTING WAS REQUIRED TO COMPLETE THE SURGERY. ANOTHER PRODUCT WAS NOT USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20205855 ↗
• InjurySep 12, 2024Failure to Cut; Material Deformation; Patient Device Interaction Problem; Failure to Cut; Material Deformation; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE BLADE WAS BOWING. THE TAKEN GRAFT WAS DAMAGED AS IT WAS NOT ABLE TO TAKE IN ONE STRIP. SUTURES WERE NOT REQUIRED AT THE HARVEST SITE. THE PATIENT REQUIRED ADDITIONAL TIME UNDER ANESTHESIA AND ADDITIONAL SKIN GRAFTING WAS REQUIRED TO COMPLETE THE SURGERY. ANOTHER PRODUCT WAS NOT USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20205499 ↗
• InjurySep 12, 2024Failure to Cut; Material Deformation; Patient Device Interaction Problem; Failure to Cut; Material Deformation; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE BLADE WAS BOWING. THE TAKEN GRAFT WAS DAMAGED AS IT WAS NOT ABLE TO TAKE IN ONE STRIP. SUTURES WERE NOT REQUIRED AT THE HARVEST SITE. THE PATIENT REQUIRED ADDITIONAL TIME UNDER ANESTHESIA AND ADDITIONAL SKIN GRAFTING WAS REQUIRED TO COMPLETE THE SURGERY. ANOTHER PRODUCT WAS NOT USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20202863 ↗
• InjurySep 12, 2024Failure to Cut; Material Deformation; Patient Device Interaction Problem; Failure to Cut; Material Deformation; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE BLADE WAS BOWING. THE TAKEN GRAFT WAS DAMAGED AS IT WAS NOT ABLE TO TAKE IN ONE STRIP. SUTURES WERE NOT REQUIRED AT THE HARVEST SITE. THE PATIENT REQUIRED ADDITIONAL TIME UNDER ANESTHESIA AND ADDITIONAL SKIN GRAFTING WAS REQUIRED TO COMPLETE THE SURGERY. ANOTHER PRODUCT WAS NOT USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20200553 ↗
• InjurySep 12, 2024Failure to Cut; Material Deformation; Patient Device Interaction Problem; Failure to Cut; Material Deformation; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE ZIMMER BLADE WAS BOWING CREATING A GAP IN THE MIDDLE. WHEN CORRECTED, THE GAP WAS ON EITHER SIDE OF THE BLADE. WHEN SKIN WAS REMOVED IT IS DONE SO UNEVENLY AND IN STRIPS RATHER THAN IN ONE PIECE. THE PATIENT REQUIRED ADDITIONAL TIME UNDER ANESTHESIA AND ADDITIONAL SKIN GRAFTING WAS REQUIRED TO COMPLETE THE SURGERY. THE HARVEST SITE DID NOT REQUIRE SUTURES. ANOTHER PRODUCT WAS NOT USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20200266 ↗
• InjurySep 12, 2024Failure to Cut; Material Deformation; Patient Device Interaction Problem; Failure to Cut; Material Deformation; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE ZIMMER BLADE WAS BOWING CREATING A GAP IN THE MIDDLE. WHEN CORRECTED, THE GAP WAS ON EITHER SIDE OF THE BLADE. WHEN SKIN WAS REMOVED IT IS DONE SO UNEVENLY AND IN STRIPS RATHER THAN IN ONE PIECE. THE PATIENT REQUIRED ADDITIONAL TIME UNDER ANESTHESIA AND ADDITIONAL SKIN GRAFTING WAS REQUIRED TO COMPLETE THE SURGERY. THE HARVEST SITE DID NOT REQUIRE SUTURES. ANOTHER PRODUCT WAS NOT USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20200217 ↗
• InjurySep 12, 2024Failure to Cut; Material Deformation; Patient Device Interaction Problem; Failure to Cut; Material Deformation; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE ZIMMER BLADE WAS BOWING CREATING A GAP IN THE MIDDLE. WHEN CORRECTED, THE GAP WAS ON EITHER SIDE OF THE BLADE. WHEN SKIN WAS REMOVED IT IS DONE SO UNEVENLY AND IN STRIPS RATHER THAN IN ONE PIECE. THE PATIENT REQUIRED ADDITIONAL TIME UNDER ANESTHESIA AND ADDITIONAL SKIN GRAFTING WAS REQUIRED TO COMPLETE THE SURGERY. THE HARVEST SITE DID NOT REQUIRE SUTURES. ANOTHER PRODUCT WAS NOT USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20200175 ↗
• MalfunctionJul 3, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY, THE UNIT DID NOT CUT PROPERLY. IT ONLY CUTS ON OUTSIDE OF UNIT, LEAVES SPACES THROUGHOUT THE MIDDLE. THERE WAS NO PATIENT HARM OR INJURY. THERE WAS NO SURGICAL DELAY. THERE WAS NO SURGICAL/MEDICAL INTERVENTION. THE TAKEN GRAFT WAS DAMAGED HOWEVER AN ADDITIONAL GRAFT WAS NOT REQUIRED TO COMPLETE THE SURGERY. ANOTHER DEVICE WAS NOT USED TO FINISH SURGERY. DURING DEVICE EVALUATION, IT WAS DISCOVERED THAT THE CUTTER MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19667026 ↗