Matrix Surgical Holdings recalls OmniPore Surgical Implants due to mislabeling

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Contact the company & request your remedy

Recalling firmMatrix Surgical Holdings, LLC4025 Welcome All Rd Sw Ste 120, N/A · Atlanta, GA 30349-1876

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Matrix Surgical Holdings is recalling specific OmniPore Surgical Implants for mislabeling. This could lead to incorrect use in craniofacial procedures if the wrong product is used.

Why it’s dangerous

Mislabeling means the product might be used incorrectly in surgery, potentially causing improper craniofacial reconstruction or trauma repair. This could lead to complications if the wrong implant is applied.

Who’s affected

Surgical patients and medical professionals who use OmniPore Surgical Implants for craniofacial reconstruction or trauma repair. Those with the specific model and lot number are most at risk.

How to tell if you have this one

Check for the model OP9520 and lot number 00855421005871 022050617 on the product packaging. These implants are used in craniofacial reconstruction and trauma repair procedures.

Brand
Matrix Surgical Holdings
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the model number OP9520 and lot number 00855421005871 022050617 on the implant packaging.

✎ GovInfoNow

Questions people ask

What is the specific model and lot number for this recall?

The model is OP9520 and the lot number is 00855421005871 022050617.

Why is this product being recalled?

The product is being recalled due to mislabeling, which could lead to incorrect use in craniofacial procedures.

Is there a remedy for this recall?

The recall record does not specify a remedy.

Take action

Contact Matrix Surgical Holdings

We’ve drafted a message you can send Matrix Surgical Holdings to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1224-2019 — Matrix Surgical Holdings Matrix Surgical Holdings

Hello,

I own a Matrix Surgical Holdings that is covered by recall Z-1224-2019 from Matrix Surgical Holdings.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1224-2019 (January 30, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1224-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Matrix Surgical Holdings, LLC recalls OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and

Recall notice