Zimmer Biomet Patient Specific Instruments recallZ-2213-2023 · Materialise N.V. · initiated Apr 26, 2023
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Materialise N.V. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The wrong tibia guide was included intended for a different patient case.
FDA root cause category: Process control
What the company is doing
Materialise notified Zimmer Biomet international logistics on April 26, 2023 via email and telephone requested return of cases. Zimmer BIomet confirmed that they would directly contact the customer to return the original cases ZB23-MAN-OLA and ZB22-UHI-NEF. Materialise shipped replacement cases on May 2, 2023 and May 3, 2023. For questions call +1-734-259-7010 or email: [email protected].
Recall details
- Recall number
- Z-2213-2023
- Status
- Completed
- Initiated by the company
- Apr 26, 2023
- Posted by the FDA
- Jul 20, 2023
- Recalling firm
- Materialise N.V.
- Quantity
- 2 Guides
- Product code
- JWH
- FDA submissions
- K221337, K173445
- Distribution
- International Distribution to countries of: Germany, Netherlands
Product description
MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01
Code information (models, lots, serial numbers)
UDI-DI: (01)05420060310027 Lot Number/Case Number: ZB22UHINEF, ZB23MANOLA
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Zimmer Biomet Patient Specific Instruments KNM-ZB02-00-01Materialise NV · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K221337, K173445 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Zimmer Biomet Patient Specific Instruments KNM-ZB03-00-01Materialise NV · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page