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 K-Wire Single Trocar 1.6x150mm surgical accessories because of a manufacturing flaw in the sterile barrier system. This could lead to contamination during orthopedic procedures if the device is used without proper sterilization.

Why it’s dangerous

The sterile barrier system has a manufacturing flaw that could allow contamination during surgical procedures. This risk is specific to orthopedic surgeries where the device is used, but not for spinal procedures.

Who’s affected

Orthopedic surgeons and medical professionals who use the K-Wire Single Trocar 1.6x150mm (Item OL15016S) for procedures like joint surgeries. Patients undergoing these procedures may be at risk if the device is used without proper sterilization.

How to tell if you have this one

Check for the item number OL15016S on the device. The product is sold under BioPro, Inc. and was manufactured on April 23, 2019, with lot number 123213. It is intended for orthopedic surgeries but not for spinal procedures.

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 OL15016S and lot number 123213 on the device.

✎ GovInfoNow

Questions people ask

Is this product safe for spinal surgeries?

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

What should I do if I have this product?

The recall does not specify a remedy, so check with BioPro for further instructions.

When was this product manufactured?

The product was manufactured on April 23, 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-2243-2019 — BioPro BioPro

Hello,

I own a BioPro that is covered by recall Z-2243-2019 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-2243-2019 (June 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2243-2019 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 1.6x150mm, Item Number OL15016S - Product Usage: Accessories to the BioPro Go-Ez screw system and

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