Device recall
Z-2355-2020: A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti…
FDA device recall · Class II · Acuity Surgical Devices, LLC
Key facts
| Recall number (Z-number) | Z-2355-2020 |
|---|---|
| Recall event | 85642 |
| Product | A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x16 7 A Link Z Ti Unitary Open Interbody 32x24x16 12 Product Usage: is a spinal device that is… |
| Product code | OVD |
| Recalling firm | Acuity Surgical Devices, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K133827 |
| FEI number | 3010866843 |
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