Device recall
Z-1428-2021: Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD…
FDA device recall · Class II · Stryker Corporation
Key facts
| Recall number (Z-number) | Z-1428-2021 |
|---|---|
| Recall event | 87540 |
| Product | Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended use for both imaging systems are being documented here. |
| Product code | GCJ |
| Recalling firm | Stryker Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 15, 2023 |
| 510(k) numbers | K150956 |
| FEI number | 2936485 |
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