Recall Z-1472-2020 ยท KWP Appliance, Fixation, Spinal Interlaminal
Medicrea International
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 B360
| 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 |