Device recall
Z-0566-2009: Rasps Model #'s: KOMKM5100-37-113 KOMKM-82 STR1675-115 STR5100-37-113 and…
FDA device recall · Class II · Sterilmed Inc
Key facts
| Recall number (Z-number) | Z-0566-2009 |
|---|---|
| Recall event | 49510 |
| Product | Rasps Model #'s: KOMKM5100-37-113 KOMKM-82 STR1675-115 STR5100-37-113 and STR5100-37-115 A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either resusable or disposable, intended to be used in various general surgical procedures. |
| Product code | HTR |
| Recalling firm | Sterilmed Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 26, 2011 |
| FEI number | 3001237663 |
At a glance
- None Linked 510(k)s
- 10–99 Products in the same recall event
- 1–9 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