Device recall
Z-2539-2015: SMR Shoulder/Spalla Trial Humeral Head diameter.42 mm, REF 9013.22.425; SMR…
FDA device recall · Class II · Limacorporate S.p.A
Key facts
| Recall number (Z-number) | Z-2539-2015 |
|---|---|
| Recall event | 71972 |
| Product | SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery. |
| Product code | KWT |
| Recalling firm | Limacorporate S.p.A |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 26, 2016 |
| 510(k) numbers | K100858 |
| FEI number | 3008021110 |
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