Drug recall
Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
FDA recall event 74213 · Class II · Materialise USA LLC
Key facts
| Event ID | 74213 |
|---|---|
| Recall numbers | Z-1941-2016 |
| Recalling firm | Materialise USA LLC |
| Product type | Devices |
| Products | Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior… |
| Initiation date | May 3, 2016 |
| Report date | Jun 15, 2016 |
| Termination date | Jun 28, 2016 |
| City | Plymouth |
| State | MI |
| Country | United States |
| FEI number | 3005718816 |
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: