Device recall
Z-1223-2019: OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore…
FDA device recall · Class II · Matrix Surgical Holdings, LLC
Key facts
| Recall number (Z-number) | Z-1223-2019 |
|---|---|
| Recall event | 82487 |
| Product | OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also… |
| Product code | KKY |
| Recalling firm | Matrix Surgical Holdings, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 23, 2020 |
| 510(k) numbers | K123908 |
| FEI number | 3009383407 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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