Z-2287-2023 Class II
FDA device recall Z-2287-2023 was initiated by Materialise N.V. on Jun 19, 2023 and is designated Class II. Reason for recall: Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request Affected quantity: 1 unit.
Recall details
- Product Type
- Devices
- Report Date
- Aug 9, 2023
- Initiation Date
- Jun 19, 2023
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2287-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026