Z-2213-2023Class II

MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)...

Name: Z-2213-2023 MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)...
Creator: Materialise N.V.
Published: 2023-04-26
License: https://open.fda.gov/license/

Materialise N.V. / initiated 2023-04-26 / Completed / root cause: manufacturing process

FDA source

Materialise N.V. began a recall of MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients... on 2023-04-26. FDA classified it as Class II and gives the reason as "The wrong tibia guide was included intended for a different patient case". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2213-2023
Classification: Class II
Status: Completed
Initiated: 2023-04-26
Posted: 2023-07-20
Recalling firm: Materialise N.V.
Product: 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
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The wrong tibia guide was included intended for a different patient case.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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].
Quantity in commerce: 2 Guides
Distribution: International Distribution to countries of: Germany, Netherlands
Product codes and lots: UDI-DI: (01)05420060310027 Lot Number/Case Number: ZB22UHINEF, ZB23MANOLA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2213-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2213-2023	Class II	Completed	Voluntary: Firm initiated	2023-07-26	2023-07-20

Product code JWH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)