Materialise N.V.: Medical Device Recall in 2023 - (Recall #: Z-2213-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: April 26, 2023

Date Posted: July 26, 2023

Recall Number: Z-2213-2023

Event ID: 92621

Reason for Recall:

The wrong tibia guide was included intended for a different patient case.

Status: Completed

Product Quantity: 2 Guides

Code Information:

UDI-DI: (01)05420060310027 Lot Number/Case Number: ZB22UHINEF, ZB23MANOLA

Distribution Pattern:

International Distribution to countries of: Germany, Netherlands

Voluntary or Mandated:

Voluntary: Firm initiated