BioPro recalls femoral head implants (22-40mm) due to potential packaging defects that could compromise sterility, risking infection after surgery. Affected units include specific part IDs and 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 femoral head implants (22mm to 40mm) because their packaging might not keep the device sterile. If the implant gets contaminated during surgery, it could lead to infection after implantation.
The packaging may have a defect that compromises the sterile barrier. If the implant is not sterile when implanted, it could introduce infection into the surgical site.
Patients who received these femoral head implants during surgery are most at risk. The recall affects specific sizes and part numbers used in hip replacements.
Check if your implant has a size between 22mm and 40mm (e.g., 22, 28, 32, 36, 40mm). Look for part IDs like 18593, 18594, 19003, etc., or serial numbers starting with M2091.
Review your implant's size (22-40mm) and part ID/serial number to confirm if it's affected.
No, this is a recall for surgical implants. If you had this implant, contact BioPro for instructions.
Part IDs 18593, 18594, 19003, 19004, 19005, 19006, 19007, 19008, 19053, 19054, 19055, 19056, 19057, 19130, 19131, 19132, 19133, 19134, 19135.
BioPro will contact affected patients directly to provide instructions for replacement or repair.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-0148-2026 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-0148-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
