Class 2 Device Recall Pass Tulip pedicle screw

• Date Initiated by Firm: January 28, 2020
• Create Date: March 11, 2020
• Recall Status: Terminated on March 17, 2023
• Recall Number: Z-1472-2020
• Recall Event ID: 84928
• 510(K)Number: K190376
• Product Classification: Appliance, fixation, spinal interlaminal - Product Code KWP
• 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 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Medicrea International; 5389 Route De Strasbourg; Vancia; Rillieux La Pape France
• Manufacturer Reason for 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.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 3529
• Distribution: Worldwide distribution - US Nationwide distribution in the states of CO, FL, GA, LA, OH, and RI. International distribution to Greece and Portugal.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWP and Original Applicant = Medicrea International S.A.