BioPro recalls Go-EZ Screw 6.5x30 (Item 19651) 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 6.5x30 accessories (Item 19651) 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 is a risk to the sterility of the surgical site but does not cause immediate injury or death in normal use.
Orthopedic surgeons and medical facilities using BioPro Go-Ez screw accessories with the BioPro HBS system. Patients undergoing surgery with these accessories are at risk if the sterile barrier fails.
Check for the item number 19651 on the Go-EZ Screw 6.5x30 accessories. These are used with the BioPro HBS system for orthopedic surgeries, not spine procedures. The lot number is 123105 and manufacturing date is April 26, 2019.
Look for item number 19651 on the Go-EZ Screw 6.5x30 accessories used with the BioPro HBS system.
The recall is due to a potential manufacturing flaw in the sterile barrier system, which could lead to contamination during surgery. However, the product is not intended for spine procedures.
The recall does not specify a remedy, so no action is required beyond checking if you have the item number 19651.
No, this product is intended for orthopedic surgical procedures but not for spine procedures.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-2246-2019 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-2246-2019 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.
