OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants i...

FDA Device Recall #Z-1224-2019 — Class II — January 30, 2019

Recall Summary

Recall Number Z-1224-2019
Classification Class II — Moderate risk
Date Initiated January 30, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Matrix Surgical Holdings, LLC
Location Atlanta, GA
Product Type Devices
Quantity 42

Product Description

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.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of Florida and Massachusetts and countries of Argentina, Chile, Colombia, Iran, Mexico, Norway, Taiwan, and Turkey.

Lot / Code Information

OP9520 / Lot # 00855421005871 022050617

Other Recalls from Matrix Surgical Holdings, LLC

Recall # Classification Product Date
Z-1223-2019 Class II OMNIPORE Surgical Implant Petite Paranasal - ... Jan 30, 2019
Z-1382-2017 Class II OP7543 Design Y Mandible Onlay - Medium - Left ... Jan 25, 2017

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.