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

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

BioPro is recalling K-Wire Sterile Single Trochar (Item 19106) because of a manufacturing flaw in the sterile barrier system. This could lead to contamination during orthopedic surgeries, especially if used in procedures not intended for the product.

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 improper healing if the product is used in procedures it's not designed for, like spine surgeries.

Who’s affected

Medical professionals using this trochar for orthopedic surgeries are likely affected. The risk is highest for those using it in procedures outside the intended scope, such as spine surgeries.

How to tell if you have this one

Check for the item number 19106 on the product. The product was sold with lot number 123130 and manufactured on April 29, 2019. It's intended for orthopedic surgeries but not for spine procedures.

Brand
BioPro
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for item number 19106, lot number 123130, and manufacturing date April 29, 2019 on the product.

✎ GovInfoNow

Questions people ask

Is this product safe for spine surgeries?

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

What should I do if I have this product?

The recall record does not specify a remedy, so contact BioPro directly for guidance.

When was this product manufactured?

The product was manufactured on 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-2240-2019 — BioPro BioPro

Hello,

I own a BioPro that is covered by recall Z-2240-2019 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-2240-2019 (June 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2240-2019 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, Item Number 19106 - Product Usage: Accessories to the BioPro Go-Ez screw system and the

Recall notice