BioPro Go-EZ Screw 6.5x90 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 6.5x90 (Item Number 19666) because of a manufacturing flaw in the sterile barrier system. This could lead to contamination during orthopedic surgeries if the screw is used without proper sterilization.

Why it’s dangerous

The sterile barrier system has a manufacturing flaw that could allow contamination during surgical procedures. This may happen if the screw is not properly sterilized before use, potentially leading to infections or other complications.

Who’s affected

Orthopedic surgeons and hospitals using the Go-EZ Screw 6.5x90 (Item 19666) for surgical procedures are likely affected. Patients undergoing orthopedic surgery with this screw may be at risk if the sterile barrier is compromised.

How to tell if you have this one

Check for the product name 'Go-EZ Screw 6.5x90', item number 19666, and lot number 123113 manufactured on April 29, 2019. This product is intended for orthopedic surgical procedures but not for spinal surgeries.

Brand
BioPro
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the item number, lot number, and manufacturing date to confirm if your screw is affected.

✎ GovInfoNow

Questions people ask

Is this product safe for spinal surgery?

No, this product is not intended for use in spinal surgeries.

What is the lot number for this product?

Lot number 123113.

How can I tell if my screw is affected?

Check for item number 19666, lot number 123113, and manufacturing date April 29, 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-2252-2019 — BioPro BioPro

Hello,

I own a BioPro that is covered by recall Z-2252-2019 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-2252-2019 (June 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2252-2019 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 6.5x90, Item Number 19666 - Product Usage:Accessories to the BioPro Go-Ez screw system and the BioPro HBS

Recall notice