Drug recall
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical…
FDA recall event 72425 · Class II · Materialise N.V.
Key facts
| Event ID | 72425 |
|---|---|
| Recall numbers | Z-0162-2016 |
| Recalling firm | Materialise N.V. |
| Product type | Devices |
| Products | Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed. |
| Initiation date | Sep 23, 2015 |
| Report date | Nov 4, 2015 |
| Termination date | Feb 12, 2016 |
| City | Heverlee |
| Country | Belgium |
| FEI number | 3003998208 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: