Materialise N.V. Recall 92732
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
Materialise N.V. Recall 92732 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2287-2023 |
| Event ID | 92732 |
| Event 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 Type | Devices |
| Distribution | US Nationwide distribution in the state of KY. |
| Quantity | 1 unit |
| Recall Reason | Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request |
| Device Classification | 20230809 |
| Device Code Info | UDI: 05420060351013 Lot Case Number: MU23-JOQ-LID |
| Center Classification Date | 20230803 |
| Recall Initiation Date | 20230619 |
| Recalling Firm | Materialise N.V. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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