Device recall
Z-1321-2016: TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF…
FDA device recall · Class II · ArthroCare Corporation
Key facts
| Recall number (Z-number) | Z-1321-2016 |
|---|---|
| Recall event | 73525 |
| Product | TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01 |
| Product code | GEI |
| Recalling firm | ArthroCare Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 17, 2017 |
| 510(k) numbers | K080282 |
| FEI number | 3010813691 |
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