Class 2 Device Recall OmniPore Surgical ImplantsRight

• Date Initiated by Firm: January 30, 2019
• Create Date: April 27, 2019
• Recall Status: Terminated on June 23, 2020
• Recall Number: Z-1224-2019
• Recall Event ID: 82487
• 510(K)Number: K123908
• Product Classification: Material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction - Product Code KKY
• 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.
• Code Information: OP9520 / Lot # 00855421005871 022050617
• Recalling Firm/ Manufacturer: Matrix Surgical Holdings, LLC; 4025 Welcome All Rd Sw Ste 120; Atlanta GA 30349-1876
• For Additional Information Contact: Vicky Cloutier; 951-326-0131
• Manufacturer Reason for Recall: Product mislabeling.
• FDA Determined Cause: Employee error
• Action: Distributor are being instructed to return all affect product in their inventory to Matrix Surgical. Additionally, they are being instructed to contact the user they have distributed affect product to and attempt to retrieve product or confirm use. If product is retuned by the User to the Distributor, then the Distribution is to return the product to the Matrix Surgical. NOTE: All product was distributed outside of the United States where all User distribution is managed by Distributors. The product will be retuning utilizing a Returns Goods Authorization per our internal procedures and reconciled. Retuned and quarantined product will be destructed by removing the product from sterile packaging and dispose per internal non-conforming product procedures. Segregate and hold current inventory on hand Contact customer whom have received the product in question and confirm their inventory quantity or usage. Have your customer return any unused product to your facility. Complete the attached Reconciliation Worksheet and return to Maria Martin at mmartin@matrixsurgicalusa.com no later than February 15, 2019. Upon receipt of completed worksheet, an RGA (Return Good Authorization) will be issued by Matrix Surgical USA. 6. Product replacements will be provided for all items received and Matrix Surgical USA will be responsible for the costs your company incurs due to this recall.
• Quantity in Commerce: 42
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KKY