Device recall
Z-1239-2010: PROMOS Inclination set, SIZE 20mm, REF 42 180, S&N 75006722, QTY: (1), STERILE…
FDA device recall · Class II · Smith & Nephew Inc
Key facts
| Recall number (Z-number) | Z-1239-2010 |
|---|---|
| Recall event | 54891 |
| Product | PROMOS Inclination set, SIZE 20mm, REF 42 180, S&N 75006722, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland. The device is used as a semi-constrained, metal/polymer cemented shoulder prosthesis. |
| Product code | KWS |
| Recalling firm | Smith & Nephew Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 10, 2012 |
| 510(k) numbers | K063578 |
| FEI number | 1020279 |
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