FDA Medical Device Recalls (openFDA)
Matrix Surgical Holdings, LLC: 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.
- Recall number
- Z-1223-2019
- Recalling firm
- Matrix Surgical Holdings, LLC
- 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.
- Status
- Terminated
- Initiated
- 2019-01-30
- Posted
- not on file
- Terminated
- 2020-06-23
- Reason
- Product mislabeling.
- Root 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
- 46
- 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.
- Lot, serial or model codes
- OP9519 / Lot # 00855421005864 021050617
- 510(k) numbers
- ["K123908"]
- PMA numbers
- not on file
- Product code
- KKY
- Firm FEI
- 3009383407
- Firm city
- Atlanta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28