Medicrea International recalls pedicle screws (article numbers B36004525-B36009560) due to incorrect internal component assembly that may cause tulip head disengagement during surgery.
An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.
Medicrea International is recalling pedicle screws of multiple sizes (article numbers B36004525 to B36009560) because an internal component was assembled incorrectly. This could cause the tulip head to detach from the screw during or after insertion, potentially leading to complications in spinal surgery.
The screws contain an internal component assembled in the wrong orientation. This defect may cause the tulip head to become disengaged from the screw's crew shank during or after insertion, which could compromise spinal stability during surgery or recovery.
Surgical professionals and patients who have received these pedicle screws for spinal fusion procedures are affected. The risk is primarily for individuals using the screws in medical settings where precise assembly is critical.
Check for pedicle screws with article numbers starting with B36004525 through B36009560. These screws are made of titanium alloy Ti-6Al-4V LI and conform to ISO5832-3 and ASTM F136 specifications.
Identify if your pedicle screws have article numbers from B36004525 to B36009560.
The internal component was assembled incorrectly, which may cause the tulip head to disengage from the screw during or after insertion.
The defect could lead to the tulip head detaching from the screw during or after insertion, potentially causing spinal instability during surgery or recovery.
Look for article numbers starting with B36004525 through B36009560 on the packaging or documentation.
We’ve drafted a message you can send Medicrea International to request your refund or repair — edit it as you like.
Subject: Recall Z-1472-2020 — Medicrea International Medicrea International Hello, I own a Medicrea International that is covered by recall Z-1472-2020 from Medicrea International. 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.
