BioPro recalls Go-EZ Screw 6.5x34 (Item 19653) 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 6.5x34 accessories (Item 19653) because of a manufacturing flaw in the sterile barrier system. This could lead to contamination during surgical procedures if the barrier fails.
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 barrier fails to maintain sterility.
Orthopedic surgeons and medical facilities using the Go-EZ Screw 6.5x34 accessories with the BioPro HBS system are likely affected. Patients undergoing surgery with these accessories may be at risk if the sterile barrier fails.
Check for the item number 19653 on the Go-EZ Screw 6.5x34 accessories. These accessories are used with the BioPro HBS system and were manufactured with lot number 123107 on April 26, 2019.
Look for item number 19653 on the Go-EZ Screw 6.5x34 accessories used with the BioPro HBS system.
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 without the recall action.
The recall does not specify a remedy, so the official notice does not provide instructions on what to do with the product.
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-2250-2019 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-2250-2019 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.
