BioPro K-Wire Single Trocar 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 its K-Wire Single Trocar 2.5x150mm (Item OL15025S) because of a manufacturing flaw in the sterile barrier system. This could lead to contamination during surgical procedures, which is a serious risk for patients undergoing orthopedic surgery.

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, but not for spine procedures.

Who’s affected

Orthopedic surgeons and medical facilities using this trocar for procedures outside the spine. Patients undergoing orthopedic surgery are at risk if the trocar is used improperly.

How to tell if you have this one

Check for the item number OL15025S on the trocar. The product was manufactured from April 24, 2019, with lot number 123219. It is used with BioPro Go-Ez screw systems and HBS systems for orthopedic 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 OL15025S and lot number 123219 on the trocar packaging or label.

✎ GovInfoNow

Questions people ask

Is this product safe for spine procedures?

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

What is the manufacturing date of the affected units?

The affected units were manufactured on April 24, 2019.

How can I tell if I have the recalled product?

Check for item number OL15025S and lot number 123219 on the trocar.

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-2245-2019 — BioPro BioPro

Hello,

I own a BioPro that is covered by recall Z-2245-2019 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-2245-2019 (June 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2245-2019 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 Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the BioPro Go-Ez screw system and

Lower-risk recall