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 i Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 i
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
A medical device manufacturer is recalling Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B3600454 due to An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after scr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On January 28, 2020, the firm notified affected customers of the recall via email. Customers were informed that affected lots may include screws which were incorrectly assembled. Customers were instructed to do the following: - Immediately check your internal inventory and quarantine the recalled product. Document results and coordinate with Medicrea International to return any nonconforming devices identified. - Inform all interested/affected parties. - Inform Medicrea International if any of the recalled devices have been distributed to other organizations. Provide contact details so that Medicrea International can inform the recipients appropriately. Distributors are responsible for retrieving the product. -Complete the customer response form attached to the customer notification even if you no longer have any physical inventory on site.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026