Drug recall
Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are…
FDA recall event 79219 · Class II · Signature Orthopedics Pty Limited
Key facts
| Event ID | 79219 |
|---|---|
| Recall numbers | Z-0920-2018 |
| Recalling firm | Signature Orthopedics Pty Limited |
| Product type | Devices |
| Products | Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may… |
| Initiation date | Feb 2, 2018 |
| Report date | Mar 14, 2018 |
| Termination date | Aug 8, 2018 |
| City | Sydney |
| Country | Australia |
| FEI number | 3008262872 |
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: