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OmniPore Surgical Implant recallZ-1224-2019 · Matrix Surgical Holdings, LLC · initiated Jan 30, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Matrix Surgical Holdings, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Product mislabeling.

FDA root cause category: Employee error

What the company is doing

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.

Recall details

Recall number
Z-1224-2019
Status
Terminated
Initiated by the company
Jan 30, 2019
Recalling firm
Matrix Surgical Holdings, LLC
Quantity
42
Product code
KKY
FDA submissions
K123908
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 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.

Code information (models, lots, serial numbers)

OP9520 / Lot # 00855421005871 022050617

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

8 devices cleared under K123908 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 82487).

Sources and updates

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