Home / Recalls / Materialise N.V. / Z-2213-2023

Z-2213-2023 Class II

Recalled by Materialise N.V. — Heverlee, N/A

FDA device recall Z-2213-2023 was initiated by Materialise N.V. on Apr 26, 2023 and is designated Class II. Reason for recall: The wrong tibia guide was included intended for a different patient case. Affected quantity: 2 Guides.

Recall details

Product Type: Devices
Report Date: Jul 26, 2023
Initiation Date: Apr 26, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2 Guides

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

Reason for recall

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

Distribution pattern

International Distribution to countries of: Germany, Netherlands

Code information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2213-2023
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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