Device recall
Z-1645-2020: BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-1645-2020 |
|---|---|
| Recall event | 85153 |
| Product | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192. |
| Product code | KWY |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 29, 2021 |
| 510(k) numbers | K080979, K161166 |
| FEI number | 1825034 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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