BioPro Go-EZ Screw 6.5x110 Recall: Sterile Barrier Manufacturing Flaw

Take action

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 6.5x110 (Item 19670) because of a manufacturing flaw in the sterile barrier system. This flaw could lead to contamination during orthopedic surgeries, making the product unsafe for use.

Why it’s dangerous

The sterile barrier system has a manufacturing flaw that could allow contamination during surgical procedures. This poses a risk of infection or other complications for patients undergoing orthopedic surgery.

Who’s affected

Orthopedic surgeons and medical facilities using the Go-EZ Screw 6.5x110 (Item 19670) for procedures other than spine surgery 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 19670 on the Go-EZ Screw 6.5x110. The product was sold with lot number 123117 and manufactured on April 26, 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 19670 and lot number 123117 on the Go-EZ Screw 6.5x110 to confirm if it is affected.

✎ GovInfoNow

Questions people ask

Is this product safe for use in spine surgery?

No, this product is not intended for use in spine surgery. It is designed for other orthopedic procedures.

What should I do if I have this product?

The recall does not specify a remedy, so check with BioPro for further instructions.

When was this product manufactured?

The product was manufactured on April 26, 2019.

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-2256-2019 — BioPro BioPro

Hello,

I own a BioPro that is covered by recall Z-2256-2019 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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-2256-2019 (June 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2256-2019 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 6.5x110, Item Number 19670 - Product Usage:Accessories to the BioPro Go-Ez screw system and the BioPro HBS

Recall notice