Atlanta, GA, United States
Matrix Surgical Holdings, LLC recalls
1 recall recorded since 2018, most recently on 30 January 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 30 January 2019
- Terminated
- 23 June 2020
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1223-2019, Z-1224-2019
- 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/cosmet
- 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/cosmet
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.