MeshgraftTM II Tissue Expansion SystemRecalls & reported problems across all models
Zimmer Orthopaedic Surgical Products, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one MeshgraftTM II Tissue Expansion System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 1
We found 3 models of MeshgraftTM II Tissue Expansion System by Zimmer Orthopaedic Surgical Products, Inc. in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Oct 4, 2021 and Aug 3, 2026 — classified as 9 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (22 reports).
1 FDA recall record name at least one of these models by its device 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. 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
MeshgraftTM II Tissue Expansion System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 2, 2024Open, 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 MeshgraftTM II Tissue Expansion System problems
Device problems
- Delivered as Unsterile Product22
- Failure to Cut6
- Patient Device Interaction Problem6
- Activation Problem5
- Activation Failure4
- Incorrect Measurement4
- Unsealed Device Packaging4
- Packaging Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- Laceration(s)6
- Skin Tears5
- Graft failure2
- Abrasion1
- Impaired Healing1
- Insufficient Information1
MeshgraftTM II Tissue Expansion System models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MeshgraftTM II Tissue Expansion System 00-2195-013-00Expander, Surgical, Skin Graft1 recall30 reports
- MeshgraftTM II Tissue Expansion System 00-2195-012-00Expander, Surgical, Skin Graft15 reports
- MeshgraftTM II Tissue Expansion System 00-2195-014-00Expander, Surgical, Skin Graft3 reports
Recent MeshgraftTM II Tissue Expansion System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2026Incorrect Measurement
Patient problems: Insufficient Information
MAUDE report 50117301 ↗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 ↗MalfunctionMar 16, 2026Delivered as Unsterile Product
No further event information is available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24605054 ↗InjuryFeb 23, 2026Incorrect Measurement; Device Markings/Labelling Problem
IT WAS REPORTED THAT DURING SURGERY THE PLATE THAT WAS USED WAS A DIFFERENT SIZE THAN WHAT WAS INDICATED ON THE PACKAGING. THE INDICATED SIZE ON THE PACKAGE WAS 1.5:1 BUT IT WAS A 3:1 RATIO. THERE WAS A LARGER HOLE IN THE TAKEN GRAFT BUT THE GRAFT WAS UTILIZED ON THE PATIENT. THE TAKEN GRAFT DID NOT LOOK GOOD SEVERAL DAYS LATER AS IT WAS MUSHY AND SMELLED BAD. IT WAS TREATED WITH SALINE-SOAKED COMPRESSES FOR ONE WEEK WITH DRESSING CHANGES. THERE WAS NO DELAY IN THE PROCEDURE. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Impaired Healing
MAUDE report 24421732 ↗MalfunctionFeb 17, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT PRODUCTS WERE FOUND TO BE NONCONFORMING DUE TO THE PRESENCE OF A FOREIGN SUBSTANCE. THE ISSUE WAS IDENTIFIED BY THE DISTRIBUTORSHIP DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE; THERE IS NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24364046 ↗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 ↗
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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