Medicrea International Pedicle Screws Recall: Incorrect Assembly Risk
Medicrea International recalls pedicle screws (article numbers B36004525-B36009560) due to incorrect internal component assembly that may cause tulip head disengagement during surgery.
Lower-risk recall
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/65946-medicrea-international-pedicle-screws-recall-incorrect-assembly-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/65946-medicrea-international-pedicle-screws-recall-incorrect-assembly-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1472-2020
Cite this page
“Medicrea International Pedicle Screws Recall: Incorrect Assembly Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65946-medicrea-international-pedicle-screws-recall-incorrect-assembly-risk. Based on FDA recall #Z-1472-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1472-2020%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Medicrea International- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide distribution - US Nationwide distribution in the states of CO, FL, GA, LA, OH, and RI. International distribution to Greece and Portugal.
| Recall number | Product, codes & lots |
|---|---|
| Z-1472-2020 | Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B36005540 B36005545 B36005550 B36005555 B36005560 B36006530 B36006535 B36006540 B36006545 B36006550 B36006555 B36006560 B36007535 B36007540 B36007545 B36007550 B36007555 B36007560 B36008535 B36008540 B36008545 B36008550 B36008555 B36008560 B36009535 B36009540 B36009545 B36009550 B36009555 B36009560 Screws manufactured in titanium alloy Ti-6Al-4V LI conforming to ISO5832-3 and ASTM. F136 specifications. These screws are part of an internal fixation system composed of hooks, rods, plates, cross links, connection and locking devices.; Lots 19C0644 19J1008 19C0645 19J1009 19C0646 19G1063 19J1010 19C0647 19G1065 19J1011 19C0648 19J1012 19C0649 19J1013 19C0650 19J1014 19C0269 19C0269R 19H0458 19C0270 19C0270R 19H0459 19J0440 19L0471 19C0271 19C0271R 19D0219 19H0460 19J0441 19L0205 19L0472 19C0272 19D0220 19C0272R 19H0463 19J0442 19L0206 19C0273 19D0221 19C0273R 19H0464 19J0443 19C0274 19C0274R 19D0222 19C0275 19C0275R 19H0467 19B0847 19B0847R 19L0209 19L0473 19B0848 19D0223 19B0848R 19F0226 19L0214 19B0849 19D0224 19B0849R 19F0227 19L0217 19L0475 19B0851 19D0225 19B0851R 19E0637 19F0267 19G0734 19H0468 19J0870 19L0219 19L0478 19B0852 19D0226 19B0852R 19E0638 19F0229 19J0676 19K0946 19L0220 19L0490 19B0853 19B0853R 19F0232 19L0221 19L0492 19B0854 19D0227 19B0854R 19F0228 19C0638 19G0735 19L0222 19L0494 19D0228 19C0639 19G0738 19L0497 19D0229 19C0640 19G0739 19D0230 19C0641 19G0745 19C0642 19G0746 19L0498 19C0643 19G0747 19D0435 19G0524 19J0444 19K0947 19D0373 19G1066 19J0668 19K0948 19D0374 19G1067 19J0671 19K0949 19D0375 19G1068 19J0672 19K0950 19L0500 19D0433 19G1069 19J0673 19D0436 19G1070 19J0675 19K0951 19D0438 19D0437 19D0439 19D0376 19D0440 19D0441 |
| Z-1473-2020 | Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580 B36027590 B36028500 B36028570 B36028580 B36028590 B36029500 B36029570 B36029580 B36029590 Screws manufactured in titanium alloy Ti-6Al-4V LI conforming to ISO5832-3 and ASTM. F136 specifications. These screws are part of an internal fixation system composed of hooks, rods, plates, cross links, connection and locking devices.; Lots 19D0683 19D0684 19D0685 19D0686 19D0369 19H0470 19D0370 19H0473 19D0371 19G1071 19L0501 19D0372 19G1073 19D0570 19G1075 19J0445 19D0571 19G1076 19J0867 19D0572 19G0521 19J0868 19L0526 19L0502 19L0525 19D0573 19G0522 19J0869 19D0574 19G1077 19L0503 19D0575 19H0474 19D0576 19G0523 19G1078 19D0577 19G1079 19H0475 |
What to do — step by step
Check Product Details
Identify if your pedicle screws have article numbers from B36004525 to B36009560.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 6 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of CO, FL, GA, LA, OH, and RI. International distribution to Greece and Portugal.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Colorado, Florida, Georgia, Louisiana, Ohio, Rhode Island.
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1472-2020 (January 28, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1472-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.