BioPro Go-EZ Screw 6.5x36 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 6.5x36 (Item 19654) 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 contamination if the screw is used without proper sterilization, potentially causing infections.

Who’s affected

Orthopedic surgeons and medical facilities using the Go-EZ Screw 6.5x36 (Item 19654) with the BioPro HBS system are likely affected. Patients undergoing orthopedic surgery with this product are at risk of contamination.

How to tell if you have this one

Check for the item number 19654 on the Go-EZ Screw 6.5x36. The product is sold with the BioPro HBS system and used in orthopedic surgeries, not spine procedures.

Brand
BioPro
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the item number 19654 on the Go-EZ Screw 6.5x36 accessory. The product is used with the BioPro HBS system for orthopedic surgeries.

✎ 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 intended for spine surgeries.

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 used for spine surgery?

No, the product is intended for orthopedic surgical procedures but not for spine procedures.

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-2248-2019 — BioPro BioPro

Hello,

I own a BioPro that is covered by recall Z-2248-2019 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-2248-2019 (June 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2248-2019 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 6.5x36, Item Number 19654 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS

Recall notice