MESHGRAFTRecalls & reported problems across all models
Zimmer Orthopaedic Surgical Products, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 66
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 2 models of MESHGRAFT by Zimmer Orthopaedic Surgical Products, Inc. in the FDA's device registry (GUDID). Together they are named in 66 adverse event reports in the FDA's MAUDE database, received between Apr 13, 2021 and Jul 9, 2026 — classified as 3 injuries, 63 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (54 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MESHGRAFT problems
Device problems
- Failure to Cut54
- Physical Resistance/Sticking5
- Dull, Blunt3
- Patient Device Interaction Problem3
- Break2
- Failure to Advance2
- Material Deformation2
- Naturally Worn2
Patient problems
- No Clinical Signs, Symptoms or Conditions57
- Insufficient Information6
- Graft failure4
- Laceration(s)2
- Abrasion1
MESHGRAFT models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MESHGRAFT™ 00-2195-000-00EXPANDER, SURGICAL, SKIN GRAFT41 reports
- MESHGRAFT™ 00-2195-001-00EXPANDER, SURGICAL, SKIN GRAFT25 reports
Recent MESHGRAFT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2026Retraction Problem
IT WAS REPORTED THAT THE DURING KIT INSPECTION, THE RATCHET HANDLE DOES NOT PERFORM THE UP OR DOWN. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25761843 ↗MalfunctionFeb 17, 2026Failure to Cut
IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE DEVICE DID NOT CUT THROUGH AT ALL PLACES. THERE WAS NO PATIENT INJURY, OR DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370562 ↗MalfunctionDec 9, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE DEVICE UNEVENLY SCORERS THE SKIN. NO EFFECT ON THE PATIENT'S CONDITION, SKIN WAS NOT INCISED DEEPLY ENOUGH. DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23756553 ↗MalfunctionDec 8, 2025Loose or Intermittent Connection; Failure to Advance; Failure to Cut; Loose or Intermittent Connection; Failure to Advance; Failure to Cut
IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE MESHER DOESN¿T CUT THROUGH IN ALL PLACES. IT ¿CHEWS¿ WHEN IT¿S SUPPOSED TO DRIVE THE PLATE FORWARD, AND SOMETIMES IT DOESN¿T GRAB THE PLATE AT ALL. IT FEELS LOOSE ACCORDING TO THE DOCTOR. PATIENT IMPACT IS UNKNOWN. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Graft failure; Insufficient Information
MAUDE report 23741677 ↗MalfunctionNov 24, 2025Failure to Advance; Failure to Advance
IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE BACK-AND-FORTH MECHANISM WAS DEFECTIVE. IT DAMAGES THE GRAFT AND DOES NOT ALLOW IT TO BE MOVED BACKWARD (THE HANDLE). PATIENT IMPACT IS UNKNOWN. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION IS AVAILABLE, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION.
Patient problems: Graft failure
MAUDE report 23632430 ↗MalfunctionNov 13, 2025Failure to Cut; Failure to Cut
THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543264 ↗MalfunctionNov 13, 2025Failure to Cut; Failure to Cut
THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543256 ↗MalfunctionOct 23, 2025Failure to Cut; Failure to Cut
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23367670 ↗MalfunctionOct 23, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN EVENT DATE. TEST GRAFTS SHOWED ¿SKIPPING¿ IN THE RESULTS. THE MESHER IS DISENGAGING AT CERTAIN POINTS DURING USE. IT IS UNKNOWN WHETHER THERE WAS ANY PATIENT IMPACT OR DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 23366715 ↗MalfunctionOct 8, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT DURING AN UNKNOWN TIME, THE UNIT WAS NOT MESHING CLEAN, IT NEEDED TO BE SHARPENED. THERE WAS NO INFORMATION AVAILABLE REGARDING THE PATIENT IMPACT. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 23246924 ↗MalfunctionJul 30, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED DURING SURGERY, THE UNIT DOES NOT PROPERLY MESH. THERE WAS NO PATIENT HARM. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE GRAFT WAS NOT DAMAGED, AND AN ADDITIONAL SKIN GRAFT WAS NOT REQUIRED TO COMPLETE THE SURGERY. THERE WAS NO SURGICAL DELAY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22666905 ↗MalfunctionJul 23, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT DURING SURGERY, THE UNIT WAS NOT CUTTING GRAFT FULLY, DOCTOR HAD TO DO IT MANUALLY. IT IS UNKNOWN IF THERE WAS PATIENT IMPACT OR SURGICAL DELAY. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22578361 ↗MalfunctionJul 17, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT DURING UNKNOWN TIMING, THE UNIT WAS ONLY MESHING TISSUE ON THE EDGES AND NOT THE ENTIRE PIECE OF SKIN. THERE WAS NO PATIENT HARM. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22533639 ↗MalfunctionJul 14, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT AT UNKNOWN EVENT TIMING, THE UNIT WAS ONLY MESHING TISSUE ON THE EDGES AND NOT THE ENTIRE PIECE OF SKIN. IT WAS NOT TAKING CLEAN SKIN GRAFTS. THERE WAS NO PATIENT HARM. DUE DILIGENCE IS COMPLETE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22495068 ↗MalfunctionJul 8, 2025Failure to Cut; Unintended Movement; Failure to Cut; Unintended Movement
IT WAS REPORTED THAT DURING SURGERY, THE UNIT WAS SHOWING ¿SKIPPING¿ IN THE RESULTS. MESHER WAS DISENGAGING AT CERTAIN POINTS DURING USE. THE DEVICE WAS TESTED MULTIPLE TIMES TO VERIFY CALIBRATION AND IT WAS MISSING CUTS DURING TESTING FROM CUSTOMER. IT WAS CONFIRMED THAT MESHER WAS TESTED PRIOR TO USE IN HARVESTED TISSUE SO NO DAMAGE CAUSED TO TISSUE AN ALTERNATE MEANS OF PREPARING THE GRAFT WAS UTILIZED. THERE WAS NO PATIENT HARM OR DELAY. DUE DILIGENCE IS COMPLETE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22438007 ↗
Other Zimmer Orthopaedic Surgical Products, Inc. products
All Zimmer Orthopaedic Surgical Products, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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