BioPro K-Wire Single Trocar Recall: Sterile Barrier Manufacturing Flaw

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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 its K-Wire Single Trocar 2.5x170mm surgical tool because of a manufacturing flaw in the sterile barrier. This could lead to contamination during surgery if the device is used improperly. The recall affects specific models made between April 2019 and Lot 123218.

Why it’s dangerous

The sterile barrier in the device may not function properly during surgery, potentially leading to contamination of the surgical site. However, the device is designed for orthopedic procedures and not spine surgeries, which reduces the risk.

Who’s affected

Orthopedic surgeons and medical professionals who use the BioPro Go-Ez screw system or BioPro HBS System are likely affected. The risk is low as the device is not intended for spine procedures and the flaw is in the sterile barrier.

How to tell if you have this one

Check for the item number OL17025S on the device. The product was manufactured between April 2019 and Lot 123218. It is used with BioPro Go-Ez screw systems and BioPro HBS Systems for orthopedic surgeries.

Brand
BioPro
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Look for the item number OL17025S and lot number 123218 on the device.

✎ GovInfoNow

Questions people ask

Is this device safe for spine surgery?

No, the device is not intended for use in spine procedures.

What is the manufacturing date range for affected units?

The device was manufactured starting April 24, 2019, with lot number 123218.

How can I tell if I have the recalled product?

Check for item number OL17025S and lot number 123218 on the device.

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-2242-2019 — BioPro BioPro

Hello,

I own a BioPro that is covered by recall Z-2242-2019 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-2242-2019 (June 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2242-2019 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 2.5x170mm, Item Number OL17025S - Product Usage: Accessories to the BioPro Go-Ez screw system and

Lower-risk recall