Device recall
Z-2548-2018: AperFix Femoral Implant Coring Removal Drill, labeled as the following: a…
FDA device recall · Class II · Cayenne Medical Inc.
Key facts
| Recall number (Z-number) | Z-2548-2018 |
|---|---|
| Recall event | 80415 |
| Product | AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long… |
| Product code | HTO |
| Recalling firm | Cayenne Medical Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 26, 2019 |
| FEI number | 3006108336 |
At a glance
- None Linked 510(k)s
- 1–9 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