Recall Z-2213-2023— Materialise N.V.

Name: FDA recall Z-2213-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-26

Class II · Completed

Class II FDA medical device recall by Materialise N.V., initiated 2023-04-26. It names 2 FDA 510(k) clearances: K221337, K173445. 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. Reason: The wrong tibia guide was included intended for a different patient case..

Recalling firm: Materialise N.V.
Classification: Class II
Status: Completed
Initiated: 2023-04-26
Firm location: Heverlee, N/A, Belgium

510(k) clearances named in this recall

2 on FDA's record

K221337 — Materialise TKA Guide SystemMaterialise NV·cleared 2022-07-05
K173445 — Materialise TKA Guide SystemMaterialise NV·cleared 2018-02-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.