Medicrea International recalls Pedicle Screws, multiple sizes, Article Nos. B36004525 B

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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