Home / Recalls / Materialise N.V. / Z-2287-2023

Z-2287-2023 Class II

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

Recall Details

Product Type
Devices
Report Date
August 9, 2023
Initiation Date
June 19, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101

Reason for Recall

Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request

Distribution Pattern

US Nationwide distribution in the state of KY.

Code Information

UDI: 05420060351013 Lot Case Number: MU23-JOQ-LID

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