Device recall
Z-2107-2020: Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7…
FDA device recall · Class II · Quest Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2107-2020 |
|---|---|
| Recall event | 85389 |
| Product | Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers) |
| Product code | DTR |
| Recalling firm | Quest Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2024 |
| 510(k) numbers | K173716 |
| FEI number | 3001665800 |
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