OMNIPORE Surgical Implant Petite Paranasal — Class II medical device recall Z-1224-2019
Terminated recall by Matrix Surgical Holdings, LLC, reported 2019-05-08, distributed nationwide. Product mislabeling.
| Recall number | Z-1224-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Matrix Surgical Holdings, LLC, Atlanta, GA, United States |
| Recall initiated | 2019-01-30 |
| Classified | 2019-04-26 |
| Reported by FDA | 2019-05-08 |
| Terminated | 2020-06-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, CL, CO, IR, MX, NO, TR, TW |
| Quantity | 42 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00855421005871 |
| Lot numbers | 022050617 |
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.
Reason for recall
Product mislabeling.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1224-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.