BioPro Go-EZ Screw 6.5x120 Recall: Sterile Barrier Manufacturing Flaw

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Recalling firmBioPro, Inc.2929 Lapeer Rd, N/A · Port Huron, MI 48060-2558

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✎ GovInfoNow plain-language explainer

What happened, in plain English

BioPro is recalling Go-EZ Screw 6.5x120 (Item 19672) because of a manufacturing flaw in the sterile barrier system. This could lead to contamination during surgical procedures if the screw is used without proper sterilization.

Why it’s dangerous

The sterile barrier system has a manufacturing flaw that could compromise its ability to maintain sterility during surgical procedures. This might lead to infections or contamination if the screw is used without proper sterilization.

Who’s affected

Orthopedic surgeons and medical facilities using the Go-EZ Screw 6.5x120 (Item 19672) for surgical procedures. Patients undergoing orthopedic surgery with this screw are at risk of contamination.

How to tell if you have this one

Look for the Go-EZ Screw 6.5x120 with Item Number 19672. The product was sold with Lot Number 123119 and manufactured on April 29, 2019.

Brand
BioPro
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the Item Number 19672, Lot Number 123119, and Manufacturing Date of April 29, 2019.

✎ GovInfoNow

Questions people ask

Is this product safe for use?

The recall states there is a manufacturing flaw in the sterile barrier system, which could lead to contamination during surgical procedures. The product is not safe for use without addressing the flaw.

What should I do if I have this product?

The recall does not specify a remedy, so the official notice does not provide instructions on what to do with the product.

Is this product intended for spinal surgery?

No, the product is intended for various orthopedic surgical procedures but not for spinal surgery.

Take action

Contact BioPro

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

✉️ Open in email

Subject: Recall Z-2257-2019 — BioPro BioPro

Hello,

I own a BioPro that is covered by recall Z-2257-2019 from BioPro.

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-2257-2019 (June 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2257-2019 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.

BioPro, Inc. recalls Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS

Recall notice