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U.S. Department of Health and Human Services

Class 2 Device Recall Pass Tulip iliac screw

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 Class 2 Device Recall Pass Tulip iliac screwsee related information
Date Initiated by FirmJanuary 28, 2020
Create DateMarch 11, 2020
Recall Status1 Terminated 3 on March 17, 2023
Recall NumberZ-1473-2020
Recall Event ID 84928
510(K)NumberK190376 
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
ProductIliac 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.
Code Information 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 
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 2		Process control
ActionOn 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 Commerce3529
DistributionWorldwide distribution - US Nationwide distribution in the states of CO, FL, GA, LA, OH, and RI. International distribution to Greece and Portugal.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KWP
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