Drug recall
GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE…
FDA recall event 65738 · Class II · Smith & Nephew Inc
Key facts
| Event ID | 65738 |
|---|---|
| Recall numbers | Z-1996-2013 |
| Recalling firm | Smith & Nephew Inc |
| Product type | Devices |
| Products | GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts). |
| Initiation date | Jul 8, 2013 |
| Report date | Aug 28, 2013 |
| Termination date | Aug 19, 2019 |
| 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: