Materialise N.V.: Medical Device Recall in 2023 - (Recall #: Z-2287-2023)

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:

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

Product Classification:

Class II

Date Initiated: June 19, 2023

Date Posted: August 9, 2023

Recall Number: Z-2287-2023

Event ID: 92732

Reason for Recall:

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

Status: Completed

Product Quantity: 1 unit

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the state of KY.

Voluntary or Mandated:

Voluntary: Firm initiated