BioPro K-Wire HBS Sterile Accessories 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 HBS Sterile accessories (Item 19688) that have a manufacturing flaw in the sterile barrier system. This flaw could lead to contamination during surgical procedures, making the products unsafe for use in 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 improper sterilization if the accessories are used in orthopedic surgeries but not for spine procedures.

Who’s affected

Orthopedic surgeons and medical staff who use these accessories for non-spine procedures. Patients undergoing orthopedic surgery may be at risk if the accessories are used without proper sterilization.

How to tell if you have this one

Check for the product name 'K-Wire HBS Sterile', item number 19688, and UDI M209196880 with lot number 122572 manufactured on April 23, 2019.

Brand
BioPro
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the item number 19688, UDI M209196880, and lot number 122572 on the packaging or label.

✎ GovInfoNow

Questions people ask

Are these accessories safe for spine surgery?

No, these accessories are not intended for use in spine procedures.

What is the manufacturing date?

The manufacturing date is April 23, 2019.

Is there a remedy for this recall?

The recall record does not specify a remedy.

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-2239-2019 — BioPro BioPro

Hello,

I own a BioPro that is covered by recall Z-2239-2019 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-2239-2019 (June 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2239-2019 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, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS

Lower-risk recall