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.

Product mislabeling.

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 [email protected] 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.