BioPro Go-EZ Screw 6.5x38 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 Go-EZ Screw 6.5x38 (Item 19655) because a manufacturing flaw in the sterile barrier could lead to surgical complications. This affects orthopedic surgical tools used in procedures other than spine surgeries.

Why it’s dangerous

The sterile barrier system has a manufacturing flaw that could compromise its integrity during surgery. This might lead to contamination or infection risks if the screw is used in procedures where sterility is critical.

Who’s affected

Orthopedic surgeons and medical facilities using the Go-EZ Screw 6.5x38 (Item 19655) for non-spine procedures. Patients undergoing these surgeries are at risk if the flawed screw is used.

How to tell if you have this one

Check for the item number 19655 on the Go-EZ Screw 6.5x38. Look for the unique device identifier (UDI) M209196550 and lot number 123109 from April 26, 2019.

Brand
BioPro
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the item number, UDI, and lot number to confirm if your Go-EZ Screw 6.5x38 is affected.

✎ GovInfoNow

Questions people ask

Is this screw safe for spine surgery?

No, this screw is not intended for spine procedures and is only for orthopedic surgeries outside the spine.

What is the lot number for affected units?

Affected units have lot number 123109 from April 26, 2019.

How can I tell if my screw is recalled?

Check for item number 19655, UDI M209196550, and lot number 123109 from April 26, 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-2258-2019 — BioPro BioPro

Hello,

I own a BioPro that is covered by recall Z-2258-2019 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-2258-2019 (June 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2258-2019 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 Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS

Recall notice