Device recall
Z-1300-2018: Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN…
FDA device recall · Class II · DePuy Spine, Inc.
Key facts
| Recall number (Z-number) | Z-1300-2018 |
|---|---|
| Recall event | 79494 |
| Product | Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathological… |
| Product code | NDN |
| Recalling firm | DePuy Spine, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 13, 2020 |
| 510(k) numbers | K060300 |
| FEI number | 1526439 |
At a glance
- 1–9 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