Device recall
Z-2602-2011: Encompass Hip Stem, Plasma Spray, 12/14 Taper, Standard, REF 108-XXXX, Sterile…
FDA device recall · Class II · Ortho Development Corporation
Key facts
| Recall number (Z-number) | Z-2602-2011 |
|---|---|
| Recall event | 58763 |
| Product | Encompass Hip Stem, Plasma Spray, 12/14 Taper, Standard, REF 108-XXXX, Sterile R, Ortho Development, Draper, Utah 84020. Intended for use in total hip arthroscopy. Device fixation is achieved by an optimal, press-fit in the medullary canal, which maximizes contact between the stem and the bone. |
| Product code | MBL |
| Recalling firm | Ortho Development Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 9, 2011 |
| 510(k) numbers | K053293 |
| FEI number | 3017298928 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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