Device product
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
Z-2287-2023
Product summary
- Firm
- Materialise N.V.
- Event
- Event 92732
- Status
- Completed
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-2287-2023
Official wording
Reason: Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
Code information: UDI: 05420060351013 Lot Case Number: MU23-JOQ-LID
Distribution pattern: US Nationwide distribution in the state of KY.
Derived failure modes
-
Unknown
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request