Zimmer Biomet Patient Specific InstrumentsRecalls & reported problems across all models
Materialise NV · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 2 models of Zimmer Biomet Patient Specific Instruments by Materialise NV in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Oct 28, 2021 and Oct 28, 2021 — classified as 1 injury.
1 FDA recall record name at least one of these models by its device identifier.
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
Zimmer Biomet Patient Specific Instruments 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.
- Apr 26, 2023Completed
The wrong tibia guide was included intended for a different patient case.
Z-2213-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported Zimmer Biomet Patient Specific Instruments problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Zimmer Biomet Patient Specific Instruments models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Zimmer Biomet Patient Specific Instruments KNM-ZB02-00-01Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall0 reports
- Zimmer Biomet Patient Specific Instruments KNM-ZB03-00-01Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
Recent Zimmer Biomet Patient Specific Instruments adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DISTAL FEMORAL RESECTIONS WERE BIGGER THAN PLANNED .THE SURGERY WAS PROLONGED FOR 100 MIN TO REDO BONE CUTS, PLAN REEVALUATION AND KNEE BALANCING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12711377 ↗
Other Materialise NV products
All Materialise NV 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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