Large QWIX
NEWDEAL · Model 121540SND · UDI-DI 10381780047896
HWC
Prescription
1
510(k) clearances
59,207
Adverse events (76 deaths)
389
Recalls
656
Facilities
Description
The QWIX positioning screw is a cannulated screw of 5.5mm diameters. It is fully threaded and has a self-tapping tip. The screw is cannulated to enable the use of a K-Wire for an optimal positioning (1.6mm K-Wire for the 5.5mm screws). It is made from titanium alloy with anodic oxidation, and color coded according to the different diameters. It is delivered sterile.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-09 | In2bones USA, LLC | Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws. |
| 2026-04-24 | Medartis AG | The cannulation of the CCS screw is not centered. |
| 2026-01-23 | I.T.S. GmbH | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). |
| 2026-01-23 | I.T.S. GmbH | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). |
| 2026-01-09 | Medartis AG | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. |
| 2026-01-09 | Medartis AG | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. |
| 2025-11-24 | Smith & Nephew, Inc. | Removal of affected lot of screws due to labeling error. |
| 2024-04-12 | Medartis Inc. | Screw is 16mm long instead of 22mm long. |
| 2024-03-20 | Zimmer, Inc. | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user sinc |
| 2024-03-20 | Zimmer, Inc. | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user sinc |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.