Medicrea recalls specific titanium iliac screws due to incorrect internal component assembly that may cause tulip heads to disengage during surgery. Affected models include Article Nos. B36020500 through B36029590.
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 is recalling multiple sizes of titanium iliac screws that may have incorrect internal assembly. This could cause the tulip head to disengage during or after screw insertion, potentially leading to complications in surgical procedures.
The screws have an internal component assembled in the wrong orientation. This can cause the tulip head to become detached from the crew shank during or after insertion, or during the reduction step of surgery. If the screw disengages, it could cause injury or require additional surgical intervention.
Orthopedic surgeons and medical professionals using these screws for spinal or hip surgeries are most at risk. Patients who have received these screws during surgery may also be affected.
Check for screws with Article Numbers B36020500 through B36029590. These screws were manufactured in titanium alloy Ti-6Al-4V LI and sold with specific lot numbers including 19D0683 through 19J0869.
Verify the Article Number and lot number on the screw packaging to confirm if it is affected.
The recall states that the screws may have incorrect internal assembly, which could cause disengagement during surgery. Affected screws should not be used until the remedy is applied.
Contact Medicrea International directly to confirm if your screws are affected and follow their instructions for safe handling or disposal.
Check for Article Numbers B36020500 through B36029590 and lot numbers 19D0683 through 19J0869 as listed in the recall notice.
We’ve drafted a message you can send Medicrea to request your refund or repair — edit it as you like.
Subject: Recall Z-1473-2020 — Medicrea Medicrea Hello, I own a Medicrea that is covered by recall Z-1473-2020 from Medicrea. 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.