BioPro recalls Go-EZ Screw 6.5x95 (Item 19667) 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 6.5x95 accessories (Item 19667) because of a manufacturing flaw in the sterile barrier system. This could lead to contamination during surgery if the product is used without proper sterilization.
The sterile barrier system has a manufacturing flaw that could allow contamination during surgical procedures. This poses a risk of infection or other complications if the product is used without proper sterilization.
Orthopedic surgeons and medical facilities that use the BioPro Go-Ez screw system and its accessories are likely affected. Patients undergoing surgery with these products may be at risk if the sterile barrier is compromised.
Check for the item number 19667 on the packaging or label. The product was sold with a lot number 123114 and manufactured on April 25, 2019.
Look for the item number 19667 on the packaging or label to confirm if you have the recalled product.
The recall states there is a manufacturing flaw in the sterile barrier system, which could lead to contamination during surgery. The product is not safe to use as is.
The recall does not specify a remedy, so you should check with BioPro directly for guidance.
No, the product is intended for various orthopedic surgical procedures but not for spine surgery.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-2249-2019 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-2249-2019 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.
