BioPro recalls Go-EZ Screw 6.5x32 (Item 19652) 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 6.5x32 accessories (Item 19652) because of a manufacturing flaw in the sterile barrier system. This could lead to contamination during surgery if the screw system is used without proper sterilization.
The sterile barrier system has a manufacturing flaw that could compromise its ability to maintain sterility during surgical procedures. If the barrier fails, it might allow contamination of the surgical site, increasing infection risk.
Orthopedic surgeons and surgical teams using the Go-EZ Screw 6.5x32 accessories with the BioPro HBS system are most at risk. Patients undergoing surgery with these accessories may be affected.
Check for the item number 19652 on the Go-EZ Screw 6.5x32 accessories. These accessories are used with the BioPro HBS system and were manufactured starting April 26, 2019.
Look for the item number 19652 on the Go-EZ Screw 6.5x32 accessories used with the BioPro HBS system.
The recall states there is a manufacturing flaw in the sterile barrier system, which could compromise sterility during surgery. The product is not safe for use without addressing the issue.
The recall does not specify a remedy, so no action is required beyond checking if you have the affected item.
No, the product is intended for 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-2254-2019 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-2254-2019 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.
