BioPro recalls Go-EZ Screw 6.5x115 (Item 19671) due to a manufacturing flaw in the sterile barrier system. This affects orthopedic surgical accessories used with the BioPro HBS system.
Manufacturing flaw in the sterile barrier system
BioPro is recalling Go-EZ Screw 6.5x115 (Item 19671) because a manufacturing flaw in the sterile barrier system could compromise surgical safety. This recall affects orthopedic surgical accessories used with the BioPro HBS system.
A manufacturing flaw in the sterile barrier system could compromise the integrity of the surgical product. This might lead to contamination or infection risks during procedures if the sterile barrier fails.
Orthopedic surgeons and medical facilities using the Go-EZ Screw 6.5x115 (Item 19671) with the BioPro HBS system are most at risk. The recall applies to products sold from April 25, 2019, onward.
Check for the item number 19671 on the Go-EZ Screw 6.5x115 accessory. Products were manufactured starting April 25, 2019, and sold for orthopedic surgical use with the BioPro HBS system.
Look for item number 19671 on the Go-EZ Screw 6.5x115 accessory.
The recall states there is a manufacturing flaw in the sterile barrier system, but the official notice does not specify if the product is safe to use without action.
The recall record does not provide a remedy or action steps for affected products.
The product was manufactured starting April 25, 2019.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-2253-2019 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-2253-2019 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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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.
