BioPro recalls Go-EZ Screw 6.5x105 (Item 19669) 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 6.5x105 (Item 19669) 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 lead to contamination or infection during surgical procedures. The product is intended for orthopedic surgeries but not for spinal procedures, which adds complexity to risk assessment.
Orthopedic surgeons and medical facilities using the Go-EZ Screw 6.5x105 (Item 19669) with the BioPro HBS system are most at risk. Patients undergoing orthopedic surgery with this product may be affected.
Check for the item number 19669 on the Go-EZ Screw 6.5x105. The product was manufactured on April 26, 2019, with lot number 123116. It is used with the BioPro HBS system for orthopedic surgeries.
Verify the item number 19669 and lot number 123116 on the Go-EZ Screw 6.5x105 to confirm if it is affected.
No, the product is intended for orthopedic surgical procedures but not for spinal procedures.
The recall record does not specify a remedy, so contact BioPro directly for guidance.
The product was manufactured on April 26, 2019.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-2255-2019 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-2255-2019 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.
