Iliac 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Iliac 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.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
A medical device manufacturer is recalling Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 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