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 | Mislabeling. The packaging labeled as left mandible contained a right mandible. |
| Product | OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right |
| Quantity | 28 |
| Distribution | Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan |
| Initiated | 2017-01-25 |
| Classified | 2017-02-28 |
| Terminated | 2017-05-24 |
| Recall number | Z-1382-2017 |
| 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-1382-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76356/
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