BioPro K-Wire Sterile Single Trochar Recall: Manufacturing Flaw in Sterile Barrier

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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 K-Wire Sterile Single Trochar .045 (Item 19108) because of a manufacturing flaw in the sterile barrier system. This could lead to contamination during surgical procedures if the product is used without proper sterility.

Why it’s dangerous

The manufacturing flaw in the sterile barrier system could allow contamination during surgical procedures. This poses a risk of infection or other complications if the product is used without proper sterility.

Who’s affected

Orthopedic surgeons and medical professionals who use this product for surgical procedures are affected. Patients undergoing orthopedic surgery with this specific accessory are at risk of contamination.

How to tell if you have this one

Check for the product name 'K-Wire Sterile Single Trochar .045', item number 19108, and lot number 123131 manufactured on April 2, 2019. This product is used with BioPro Go-Ez screw systems for orthopedic surgeries.

Brand
BioPro
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the product by checking the item number 19108, lot number 123131, and manufacturing date of April 2, 2019.

✎ GovInfoNow

Questions people ask

Is this product safe for use in spine surgery?

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

What is the manufacturing date of this product?

The manufacturing date is April 2, 2019.

How can I tell if I have the recalled product?

Look for the item number 19108, lot number 123131, and manufacturing date of April 2, 2019 on the product.

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-2241-2019 — BioPro BioPro

Hello,

I own a BioPro that is covered by recall Z-2241-2019 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-2241-2019 (June 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2241-2019 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 K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Accessories to the BioPro Go-Ez screw system and

Recall notice