BioPro recalls bipolar head implants with potential packaging defects that could compromise sterility, risking infection if implanted. Affected models include 38mm to 60mm sizes.
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 bipolar head implants (38mm to 60mm) due to a packaging defect that might compromise sterility. If implanted, this could lead to infection risks.
The packaging may not maintain sterility properly, which could allow contamination. If the device is implanted, this might lead to infection.
Patients who have received these bipolar head implants for surgery are most at risk. The recall applies to all units produced with the specified model numbers.
Check for product IDs 18130-18152 with sizes 38mm to 60mm. All lots and serial numbers are affected.
Identify your implant's size (38mm to 60mm) and product ID (18130-18152) to confirm if it's affected.
The recall does not require stopping use; it's for patients who have received the implant to check for sterility risks.
Contact BioPro directly to confirm if your implant is affected and follow their guidance.
The recall does not mention a fix; affected implants should be checked by a medical professional.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-0150-2026 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-0150-2026 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.
