Device recall
Z-1516-2017: Poly Component Trial, PS, packaged in the following sizes and configurations: a)…
FDA device recall · Class II · Medtronic Sofamor Danek USA Inc
Key facts
| Recall number (Z-number) | Z-1516-2017 |
|---|---|
| Recall event | 76694 |
| Product | Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10, REF 90-SRK-180410 e) Poly… |
| Product code | JWH |
| Recalling firm | Medtronic Sofamor Danek USA Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 27, 2017 |
| 510(k) numbers | K150496 |
| FEI number | 1000477302 |
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