Device recall
Z-1885-2017: 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack…
FDA device recall · Class II · Amendia, Inc
Key facts
| Recall number (Z-number) | Z-1885-2017 |
|---|---|
| Recall event | 77069 |
| Product | 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal surgery |
| Product code | LXH |
| Recalling firm | Amendia, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 30, 2017 |
| FEI number | 3007970248 |
At a glance
- None 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