BioPro Go-EZ Screw 6.5x85 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 6.5x85 (Item 19665) accessories for the BioPro HBS system because of a manufacturing flaw in the sterile barrier. This could lead to contamination during surgery if the barrier is compromised.

Why it’s dangerous

The sterile barrier system has a manufacturing flaw that could allow contamination during surgical procedures. This risk is specific to the Go-EZ Screw 6.5x85 (Item 19665) used in orthopedic surgeries outside of spine procedures.

Who’s affected

Orthopedic surgeons and medical facilities using the Go-EZ Screw 6.5x85 (Item 19665) for non-spine procedures. Patients undergoing surgery with these accessories are at risk if the sterile barrier fails.

How to tell if you have this one

Check for the item number 19665 on the packaging or label. The product was sold with a manufacturing date of April 26, 2019, and lot number 123112.

Brand
BioPro
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the item number 19665 and lot number 123112 on the packaging or label.

✎ GovInfoNow

Questions people ask

Is this product safe for spinal surgery?

No, this product is not intended for use in spine procedures.

What is the manufacturing date of the recalled product?

The manufacturing date is April 26, 2019.

How can I tell if I have the recalled item?

Check for item number 19665 and lot number 123112 on the packaging or label.

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-2251-2019 — BioPro BioPro

Hello,

I own a BioPro that is covered by recall Z-2251-2019 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-2251-2019 (June 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2251-2019 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 6.5x85, Item Number 19665 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS

Recall notice