Z-1224-2019Class II

OMNIPORE Surgical Implant Petite Paranasal - Right -

Name: Z-1224-2019 OMNIPORE Surgical Implant Petite Paranasal - Right -
Creator: Matrix Surgical Holdings, LLC
Published: 2019-01-30
License: https://open.fda.gov/license/

MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA / initiated 2019-01-30 / Terminated / root cause: manufacturing process

FDA source

Matrix Surgical Holdings, LLC began a recall of OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for... on 2019-01-30. FDA classified it as Class II and gives the reason as "Product mislabeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1224-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-30
Posted: 2019-04-27
Terminated: 2020-06-23
Recalling firm: MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA
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.
Product code: KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Reason for recall: Product mislabeling.
Root cause tag: manufacturing process
FDA 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 [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.
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.
Product codes and lots: OP9520 / Lot # 00855421005871 022050617

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1224-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1223-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-04-26
Z-1224-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-04-26

Product code KKY

K123908Class IIOmnipore Surgical Implants and AccessoriesMatrix Surgical USA / cleared 2013-07-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)