BioPro recalls femoral head implants due to potential packaging defects that could compromise sterility, risking infection after surgery. Affected products include specific sizes and lot numbers.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
BioPro is recalling femoral head implants that may have packaging defects risking infection if implanted. This recall affects specific product sizes and lot numbers sold to hospitals and surgical centers.
The packaging may not maintain sterility properly, which could lead to infection if the implant is placed inside the body during surgery. This defect occurs during the manufacturing process and affects the sterile barrier of the product.
Hospitals and surgical centers that purchased BioPro femoral head implants between 2020 and 2023 are likely affected. Patients who have received these implants are at risk of infection if the device is implanted.
Check for product IDs 14089, 14090, 14091, 14094, 14095, or 14096 with serial numbers starting with M20914. These implants were sold between 2020 and 2023.
Reach out to BioPro, Inc. to confirm if your specific implant is affected and get instructions for next steps.
The recall does not require immediate discontinuation; affected hospitals should check with BioPro for guidance.
The risk of infection is possible if the sterile packaging is compromised during implantation, but the exact risk level is not specified in the recall notice.
Check the product ID and serial number on the implant packaging; affected items have specific IDs like 14089 with serial numbers starting with M20914.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-0153-2026 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-0153-2026 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.
