Device recall
Z-0193-2018: pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3…
FDA device recall · Class II · Pro-Med Instruments Gmbh
Key facts
| Recall number (Z-number) | Z-0193-2018 |
|---|---|
| Recall event | 78501 |
| Product | pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery. |
| Product code | HBL |
| Recalling firm | Pro-Med Instruments Gmbh |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2018 |
| 510(k) numbers | K001808 |
| FEI number | 3003923584 |
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