Drug recall
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
FDA recall event 66545 · Class II · Smith & Nephew Inc
Key facts
| Event ID | 66545 |
|---|---|
| Recall numbers | Z-0130-2014, Z-0131-2014 |
| Recalling firm | Smith & Nephew Inc |
| Product type | Devices |
| Products | GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic, GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa. |
| Initiation date | Oct 7, 2013 |
| Report date | Nov 13, 2013 |
| Termination date | Aug 23, 2016 |
| 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: