BioPro K-Wire HBS Sterile Lot 19688: Manufacturing Flaw in Sterile Barrier

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Contact the company & request your remedy

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 a specific sterile lot of K-Wire HBS accessories for orthopedic surgery because of a manufacturing flaw in the sterile barrier system. This could lead to contamination risks during surgical procedures if the product is used without proper sterility.

Why it’s dangerous

The sterile barrier system has a manufacturing flaw that could compromise sterility during surgical procedures. This might lead to contamination risks if the product is used without proper sterility checks.

Who’s affected

Orthopedic surgeons and surgical teams using the BioPro Go-Ez screw system accessories with the specific lot number 123305 (manufactured April 11, 2019) are affected. Patients undergoing orthopedic surgery are at risk if the flawed product is used.

How to tell if you have this one

Check for the lot number 123305 on the packaging, manufactured on April 11, 2019, and the item number 19688. The product is intended for orthopedic surgery but not for spinal procedures.

Brand
BioPro
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot number 123305, manufactured date April 11, 2019, and item number 19688 on the packaging.

✎ GovInfoNow

Questions people ask

Is this product safe for spinal surgery?

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

What should I do if I have this product?

The recall record does not specify a remedy, so no action is required beyond checking the product details.

How can I confirm if I have the recalled product?

Check for the lot number 123305, manufactured on April 11, 2019, and item number 19688 on the packaging.

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-2259-2019 — BioPro BioPro

Hello,

I own a BioPro that is covered by recall Z-2259-2019 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-2259-2019 (June 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2259-2019 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 HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro

Lower-risk recall