MeshgraftTM II Tissue Expansion System 00-2195-013-00Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · 3 TO 1 DERMACARRIER · Class 1
All models of MeshgraftTM II Tissue Expansion System (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Zimmer tissue expander stretches skin before grafting. Most of the 30 reports describe units arriving not sterile, with hair or other foreign material inside or unsealed packaging, plus some failing to activate; three mention injuries such as skin tears, and no deaths. One open recall from January 2024 concerns a labeling mix-up, with units marked 3:1 actually a 1.5:1 ratio, which can mean minor tissue damage or an extra graft. Reports rose from 1 to 13.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00889024372566), received between Oct 4, 2021 and Mar 30, 2026 — classified as 3 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (16 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.
Reports received per month
Recalls naming this device
- Jan 2, 2024Class IIOpen, Classified
Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1 ratio. The problem may lead to minor tissue damage or additional unplanned graft if deemed necessary.
Z-1078-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Delivered as Unsterile Product16
- Activation Problem5
- Activation Failure3
- Packaging Problem3
- Activation, Positioning or Separation Problem2
- Failure to Cut2
- Patient Device Interaction Problem2
- Unsealed Device Packaging2
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Laceration(s)2
- Abrasion1
- Graft failure1
- Skin Tears1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INSPECTION, THE UNIT WAS FOUND TO BE NON-CONFORMING, DUE TO HAIR LIKE SUBSTANCE FOUND INTO THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24716358 ↗MalfunctionMar 30, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INSPECTION, THE UNIT WAS FOUND TO BE NON-CONFORMING, DUE TO FOREIGN SUBSTANCE FOUND INTO THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24716339 ↗MalfunctionMar 30, 2026Unsealed Device Packaging
IT WAS REPORTED THAT DURING INSPECTION, THE UNIT WAS FOUND TO BE NON-CONFORMING, DUE TO UNSEALED PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24716058 ↗MalfunctionMar 30, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INSPECTION, THE UNIT WAS FOUND TO BE NON-CONFORMING, DUE TO FOREIGN SUBSTANCE FOUND INTO THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715891 ↗MalfunctionMar 30, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INSPECTION, THE UNIT WAS FOUND TO BE NON-CONFORMING, DUE TO FOREIGN SUBSTANCE FOUND INTO THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715887 ↗MalfunctionMar 30, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INSPECTION, THE UNIT WAS FOUND TO BE NON-CONFORMING, DUE TO FOREIGN SUBSTANCE FOUND INTO THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715856 ↗MalfunctionMar 30, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INSPECTION, THE UNIT WAS FOUND TO BE NON-CONFORMING, DUE TO FOREIGN SUBSTANCE FOUND INTO THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715798 ↗MalfunctionMar 30, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INSPECTION, THE UNIT WAS FOUND TO BE NON-CONFORMING, DUE TO FOREIGN SUBSTANCE FOUND INTO THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715759 ↗MalfunctionMar 30, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INSPECTION, THE UNIT WAS FOUND TO BE NON-CONFORMING, DUE TO FOREIGN SUBSTANCE FOUND INTO THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715753 ↗MalfunctionFeb 16, 2026Delivered as Unsterile Product; Unsealed Device Packaging
IT WAS REPORTED THAT DURING INSPECTION, THE UNIT WAS FOUND TO BE NON-CONFORMING, DUE TO UNSEALED PACKAGE AND FOREIGN SUBSTANCE-LIKE HAIR FOUND IN THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS IN PROGRESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24344676 ↗InjuryJan 23, 2026Incorrect Measurement
IT WAS REPORTED THAT DURING SURGERY, THE TISSUE WAS STRETCHED SIGNIFICANTLY LESS THAN 3:1, THE TISSUE HAD TO BE DISCARDED AND A NEW ONE TAKEN. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO DELAY OCCURRED. DUE DILIGENCE IS COMPLETE AS NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Graft failure
MAUDE report 24168054 ↗MalfunctionDec 16, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR A REPORTABLE MALFUNCTION. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED AS PACKAGING IS CONFORMING AND MEETS SPECIFICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23818317 ↗MalfunctionNov 18, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED DURING THE INCOMING INSPECTION, A TEAM MEMBER FOUND WRINKLES IN THE SEALING AREA. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23586897 ↗MalfunctionNov 26, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE PACKAGING WAS WITHIN SPECIFICATIONS. IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR A REPORTABLE MALFUNCTION. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20779391 ↗InjuryOct 28, 2024Failure to Cut; Patient Device Interaction Problem; Failure to Cut; Patient Device Interaction Problem
THERE IS NO ADDITIONAL INFORMATION REGARDING THE EVENT.
Patient problems: Laceration(s); Skin Tears
MAUDE report 20547240 ↗MalfunctionJul 11, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING RECEIVING INSPECTION AT THE DISTRIBUTOR WAREHOUSE THE PRODUCT WAS FOUND TO BE NONCONFORMING. THERE WAS A FOREIGN SUBSTANCE PRESENT WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT WITH NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19725480 ↗MalfunctionMay 16, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING INCOMING INSPECTION, A TEAM MEMBER FOUND A BURR INSIDE OF THE PACKAGING. DEBRIS WAS FOUND DURING DEVICE EVALUATION. NO PATIENT INVOLVEMENT, IMPACT, OR HARM. DUE DILIGENCE INFORMATION COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19331465 ↗MalfunctionFeb 6, 2024Activation Problem; Inaccurate Information; Activation Problem; Inaccurate Information
IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE DEVICE RIPPED THE SKIN AND THE PACKAGING ALSO IDENTIFIES THE PRODUCT AS A 3:1 RATIO, BUT THE RIDGE PATTERN IS A 1.5:1 RATIO. THERE WAS NO NOTE OF PATIENT HARM OR DELAY. DUE DILIGENCE IS IN PROCESS AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18649711 ↗MalfunctionFeb 2, 2024Activation Problem; Activation Problem
IT WAS REPORTED THAT DURING SURGERY THE CARRYING SKIN GRAFT WAS MAGNIFIED TO 1.5 TO 1, ALTHOUGH THE SPECIFICATION RATE OF MAGNIFICATION OF THE PRODUCT IS 3 TO 1. THERE WAS NO NOTE OF PATIENT HARM OR DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18631409 ↗MalfunctionJan 31, 2024Appropriate Device Problem Term/Code Not Available; Activation Failure; Appropriate Device Problem Term/Code Not Available; Activation Failure
IT WAS REPORTED DURING SURGERY THAT THE DERMACARRIER IS NOT EXPANDING THE SKIN PROPERLY WHEN PUT THROUGH THE MESHER. COMPARED THE CARRIER WITH ANOTHER BOX AND THE GROOVES WERE NOTED TO BE DIFFERENT. THERE IS NO HARM OR DELAY REPORTED, DUE DILIGENCE IS IN PROGRESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18616355 ↗MalfunctionJan 23, 2024Activation Problem; Activation Problem
IT WAS REPORTED THAT DURING SURGERY THE DEVICE TORE THE SKIN GRAFT. THERE WAS NO NOTE OF PATIENT HARM AND IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE. DUE DILIGENCE IS IN PROCESS AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18562612 ↗MalfunctionDec 5, 2023Activation Failure; Activation Failure
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18265507 ↗MalfunctionDec 5, 2023Activation Failure; Activation Failure
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18265504 ↗MalfunctionSep 25, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING SURGERY, THE CARRYING SKIN GRAFT'S RATE OF MAGNIFICATION OF THIS COMPLAINT PRODUCT WAS DIFFERENT FROM THE SPECIFICATION. THE SURGEON SAID THE CARRYING SKIN GRAFT WAS MAGNIFICATED 1.5 TO 1, ALTHOUGH THE SPECIFICATION RATE OF MAGNIFICATION OF THIS COMPLAINT PRODUCT IS 3 TO 1. THERE WAS NO PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION, OR AN ADDITIONAL SURGERY REPORTED. THE TAKEN GRAFT WAS NOT DAMAGED. THERE WAS NO SURGICAL DELAY. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17809314 ↗MalfunctionSep 25, 2023Activation, Positioning or Separation Problem; Activation Problem; Activation, Positioning or Separation Problem; Activation Problem
THERE WAS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17807491 ↗
Other Expander, Surgical, Skin Graft devices
- N/A 00-7701-000-00Zimmer Orthopaedic Surgical Products, Inc. · Expander, Surgical, Skin Graft521 reports
- N/A 00-7703-015-00Zimmer Orthopaedic Surgical Products, Inc. · Expander, Surgical, Skin Graft206 reports
- N/A 00-7703-020-00Zimmer Orthopaedic Surgical Products, Inc. · Expander, Surgical, Skin Graft103 reports
- MESHGRAFT™ 00-2195-000-00Zimmer Orthopaedic Surgical Products, Inc. · EXPANDER, SURGICAL, SKIN GRAFT41 reports
- N/A 00-7703-030-00Zimmer Orthopaedic Surgical Products, Inc. · Expander, Surgical, Skin Graft33 reports
- N/A 00-7703-040-00Zimmer Orthopaedic Surgical Products, Inc. · Expander, Surgical, Skin Graft27 reports
- MESHGRAFT™ 00-2195-001-00Zimmer Orthopaedic Surgical Products, Inc. · EXPANDER, SURGICAL, SKIN GRAFT25 reports
- MeshgraftTM II Tissue Expansion System 00-2195-012-00Zimmer Orthopaedic Surgical Products, Inc. · Expander, Surgical, Skin Graft15 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 · each recall links to the FDA recall notice
- 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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