Device recall
Z-2539-2020: OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model…
FDA device recall · Class II · OrthoPediatrics Corp
Key facts
| Recall number (Z-number) | Z-2539-2020 |
|---|---|
| Recall event | 85837 |
| Product | OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction. |
| Product code | MBI |
| Recalling firm | OrthoPediatrics Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 25, 2021 |
| FEI number | 3006460162 |
At a glance
- None 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