Device recall
Z-0026-2016: Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD…
FDA device recall · Class II · Ortho Solutions Inc
Key facts
| Recall number (Z-number) | Z-0026-2016 |
|---|---|
| Recall event | 71899 |
| Product | Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw |
| Product code | HWC |
| Recalling firm | Ortho Solutions Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 26, 2017 |
| 510(k) numbers | K141784 |
| FEI number | 3022270316 |
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