[Recalled] ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. . — Pati
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. . |
|---|---|
| Brand / manufacturer | Materialise USA LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0578-2014 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 08 November 2013 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.