Device recall
Z-0920-2018: Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic…
FDA device recall · Class II · Signature Orthopedics Pty Limited
Key facts
| Recall number (Z-number) | Z-0920-2018 |
|---|---|
| Recall event | 79219 |
| Product | 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 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical… |
| Product code | MEH |
| Recalling firm | Signature Orthopedics Pty Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 8, 2018 |
| 510(k) numbers | K121297 |
| FEI number | 3008262872 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database