BioPro Go-EZ Screw 6.5x100 Recall: Sterile Barrier Manufacturing Flaw

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Contact the company & request your remedy

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

BioPro is recalling Go-EZ Screw 6.5x100 (Item 19668) because of a manufacturing flaw in the sterile barrier system. This could lead to contamination risks during orthopedic surgeries, especially since the screws are not intended for spinal procedures.

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 risks if the screws are used in procedures where sterility is critical, though the screws are not intended for spinal surgeries.

Who’s affected

Orthopedic surgeons and medical facilities using the Go-EZ Screw 6.5x100 (Item 19668) for non-spinal procedures. Patients undergoing orthopedic surgery with this screw may be at risk of contamination.

How to tell if you have this one

Check for the item number 19668 on the Go-EZ Screw 6.5x100. The product was sold with a manufacturing date of April 26, 2019, and lot number 123115.

Brand
BioPro
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for item number 19668 and lot number 123115 on the Go-EZ Screw 6.5x100.

✎ GovInfoNow

Questions people ask

Is this screw safe for spinal surgery?

No, the Go-EZ Screw 6.5x100 is not intended for use in spinal procedures.

What is the manufacturing date of the recalled screws?

The screws were manufactured on April 26, 2019.

How can I confirm if I have the recalled item?

Check for item number 19668 and lot number 123115 on the screw packaging.

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-2247-2019 — BioPro BioPro

Hello,

I own a BioPro that is covered by recall Z-2247-2019 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-2247-2019 (June 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2247-2019 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 6.5x100, Item Number 19668 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS

Recall notice