Device recall
Z-0109-2015: Microseal Augmented (20 degrees) Liner, acetabular liner component made from…
FDA device recall · Class II · Signal Medical Corporation
Key facts
| Recall number (Z-number) | Z-0109-2015 |
|---|---|
| Recall event | 69418 |
| Product | Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20. Device is intended for use with Whiteside Biomechanics, Inc./Signal Medical Corporation Micro-Seal Shell in an uncemented Total Hip Replacement. |
| Product code | LPH |
| Recalling firm | Signal Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 20, 2015 |
| 510(k) numbers | K955271 |
| FEI number | 3002477077 |
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