Drug recall
smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON…
FDA recall event 77827 · Class II · Smith & Nephew, Inc.
Key facts
| Event ID | 77827 |
|---|---|
| Recall numbers | Z-3100-2017 |
| Recalling firm | Smith & Nephew, Inc. |
| Product type | Devices |
| Products | smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction with a curved stem… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures. |
| Initiation date | Jul 24, 2017 |
| Report date | Sep 6, 2017 |
| Termination date | Aug 21, 2020 |
| 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: