Device recall
Z-2430-2018: Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are…
FDA device recall · Class II · Valeris Medical, LLC
Key facts
| Recall number (Z-number) | Z-2430-2018 |
|---|---|
| Recall event | 80069 |
| Product | Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended for: Shoulder - Rotator Cuff Repair - Bankart Repair - SLAP Lesion Repair - Biceps Tenodesis - Acromio-Clavicular Separation Repair - Deltoid Repair - Capisular Shift or Capsulolabral Reconstruction Foot/Ankle… |
| Product code | MBI |
| Recalling firm | Valeris Medical, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 9, 2021 |
| 510(k) numbers | K142230 |
| FEI number | 3010841252 |
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