Device recall
Z-1754-2015: Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem…
FDA device recall · Class III · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-1754-2015 |
|---|---|
| Recall event | 71171 |
| Product | Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular… |
| Product code | LPH |
| Recalling firm | Biomet, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 16, 2016 |
| 510(k) numbers | K003429, K030055 |
| FEI number | 1825034 |
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