Drug recall
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
FDA recall event 89031 · Class II · Smith & Nephew, Inc.
Key facts
| Event ID | 89031 |
|---|---|
| Recall numbers | Z-0363-2022, Z-0364-2022, Z-0365-2022, Z-0366-2022 |
| Recalling firm | Smith & Nephew, Inc. |
| Product type | Devices |
| Products | smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102, smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202, smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101, smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent s reports were erroneous. Erroneous data from the reports was incorporated in the released IFU… |
| Initiation date | Nov 1, 2021 |
| Report date | Dec 22, 2021 |
| City | Memphis |
| State | TN |
| Country | United States |
| FEI number | 1020279 |
At a glance
- 1–9 Products in this recall
- None 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: