FDA Device recall Z-2287-2023
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in ma…
- FDA Device
- Class II
- completed
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in ma… by Materialise N V, citing wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2287-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-06-19 |
| Published | 2023-08-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Materialise N V |
| Distribution | US |
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
Reason
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
Identifiers
| code_info | UDI: 05420060351013 Lot Case Number: MU23-JOQ-LID |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2287-2023%22
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