Recall Z-1473-2020 ยท KWP Appliance, Fixation, Spinal Interlaminal
Medicrea International
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, cr
| Date | Jan 28, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root 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 M |
| Quantity | 3529 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CO, FL, GA, LA, OH, and RI. International distribution to Greece and Portugal. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190376 | PASS LP Spinal System Medicrea International SA, May 2, 2019 |