Device recall
Z-1425-2010: Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St…
FDA device recall · Class II · Advanced Neuromodulation Systems, Inc
Key facts
| Recall number (Z-number) | Z-1425-2010 |
|---|---|
| Recall event | 55142 |
| Product | Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company. Product is intended to be used as an accessory to the leads component of ANS SCS systems, functioning to secure the lead to the fascia or interspinous/supraspinous ligament. |
| Product code | GZB |
| Recalling firm | Advanced Neuromodulation Systems, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2010 |
| 510(k) numbers | K092371 |
| FEI number | 1627487 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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