Device recall
Z-1343-04: Harmony MIS Life Instruments, Lumbar Spacer Systems manufactured by Spinal…
FDA device recall · Class II · Spinal Concepts, Inc
Key facts
| Recall number (Z-number) | Z-1343-04 |
|---|---|
| Recall event | 28977 |
| Product | Harmony MIS Life Instruments, Lumbar Spacer Systems manufactured by Spinal Concepts, Austin, Texas. Part numbers 2851-1-01, 2851-1-30, 2851-2-01, 2851-2-30, 2851-3-01, 2851-3-30, 2851-4-01, 2851-4-30, 2851-4-31, 2851-5-01, 2851-5-30, 2852-2, 2852-4, 2854-1, 2857-1, 2857-2, 2862-1, 2858-1, 2859-1… |
| Product code | MQP |
| Recalling firm | Spinal Concepts, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 20, 2004 |
| 510(k) numbers | K033517 |
| FEI number | 3000718496 |
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