Device recall
Z-3059-2017: Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES…
FDA device recall · Class II · Custom Assemblies Inc
Key facts
| Recall number (Z-number) | Z-3059-2017 |
|---|---|
| Recall event | 77962 |
| Product | Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety Biopsy Tray (f) CMS-5798-R1… |
| Product code | LRO |
| Recalling firm | Custom Assemblies Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 28, 2017 |
| FEI number | 3000718854 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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