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Completed

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

FDA Recall Z-2213-2023 · Posted 2023-07-20

Recalling FirmMaterialise N.V.
Recall StatusCompleted
Product CodeJWH
Date Initiated2023-04-26
Product Quantity2 Guides

Reason for Recall

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

Firm 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].

Root Cause

Process control

Distribution Pattern

International Distribution to countries of: Germany, Netherlands

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K221337Materialise TKA Guide SystemMaterialise NV · 2022-07-05K173445Materialise TKA Guide SystemMaterialise NV · 2018-02-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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