# FDA recall Z-1223-2019

> **Matrix Surgical Holdings, LLC** · Class II · device recall initiated 2019-01-30.

## 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 intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

## Reason for recall

Product mislabeling.

## 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.

## Key facts

- **Recall number:** Z-1223-2019
- **Recalling firm:** Matrix Surgical Holdings, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-30
- **Report date:** 2019-05-08
- **Termination date:** 2020-06-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Atlanta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1223-2019

## Citation

> AI Analytics. FDA recall Z-1223-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1223-2019. Source: US FDA. Licensed CC0.

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