BioPro recalls K-Wire Single Trocar 1.1x150mm (Item OL15011S) due to a manufacturing flaw in the sterile barrier system. This may affect orthopedic surgical procedures.
Manufacturing flaw in the sterile barrier system
BioPro is recalling K-Wire Single Trocar 1.1x150mm (Item OL15011S) because of a manufacturing flaw in the sterile barrier system. This could lead to contamination during surgical procedures if the product is used without proper sterilization.
The manufacturing flaw in the sterile barrier system could allow contamination during surgical procedures. This might lead to infections or other complications if the trocar is not properly sterilized before use.
Orthopedic surgeons and medical professionals who use this trocar for surgical procedures. Patients undergoing orthopedic surgery may be at risk if the product is used without proper sterilization.
Look for the product name 'K-Wire Single Trocar 1.1x150mm', item number OL15011S, and lot number 123220 manufactured on 4/23/2019. This product is used with BioPro Go-Ez screw systems and BioPro HBS systems for orthopedic surgeries.
Verify the item number, lot number, and manufacturing date to confirm if your product is affected.
The recall states there is a manufacturing flaw in the sterile barrier system, which could lead to contamination during surgical procedures. It is not safe to use without proper sterilization.
The recall does not specify a remedy, so check the product details to confirm if it is affected and contact BioPro for further instructions.
No, the product is not intended for use in spine surgery but for orthopedic procedures.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-2244-2019 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-2244-2019 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.
