Class II — Matrix Surgical Holdings, LLC
| Recalling firm | Matrix Surgical Holdings, LLC. dba Matrix Surgical USA |
|---|---|
| Registered facility | MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Product mislabeling. |
| Product | OMNIPORE Surgical Implant Petite Paranasal - Right - 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 intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton. |
| Quantity | 42 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Florida and Massachusetts and countries of Argentina, Chile, Colombia, Iran, Mexico, Norway, Taiwan, and Turkey. |
| Initiated | 2019-01-30 |
| Classified | 2019-04-26 |
| Terminated | 2020-06-23 |
| Recall number | Z-1224-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Matrix Surgical Holdings, LLC (Z-1224-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82487/
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