Pedicle Screws, multiple sizes, Article Nos
Medical device recall Z-1472-2020. Published in FDA’s Enforcement Report on Mar 18, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 18, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 6 states named
- 3529 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
3529, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,138 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide distribution in the states of CO, FL, GA, LA, OH, and RI. International distribution to Greece and Portugal.
The states and territories these words name
- Colorado
- Florida
- Georgia
- Louisiana
- Ohio
- Rhode Island
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 28, 2020.
- FDA classified it on Mar 11, 2020.
- FDA’s Enforcement Report published it on Mar 18, 2020.
- FDA terminated it on Mar 17, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medicrea International, of Rillieux La Pape, France.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.