QWIX®
NEWDEAL · Model 119940ND · UDI-DI 10381780126546
FSM
Prescription
10
510(k) clearances
2,280
Adverse events (2 deaths)
36
Recalls
874
Facilities
Description
The container is used in the transport and the sterilization of the QWIX® associated instruments. It includes one combined base with reference 119941ND and one lid with reference 996200ND. The transport and sterilization containers are not intended to maintain sterility.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-18 | Encore Medical, LP | Their is a potential that the reamer may kick or bind up during or immediately prior to use. |
| 2024-06-11 | Medical Action Industries, Inc. 306 | The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomenclature) code. These blue foa |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2023-11-15 | MEDLINE INDUSTRIES, LP - Northfield | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile |
| 2023-02-23 | Aesculap Implant Systems LLC | Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607. |
| 2022-12-15 | Stradis Healthcare | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
| 2022-12-15 | Stradis Healthcare | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
| 2021-11-24 | Howmedica Osteonics Corp. | Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: |
| 2019-06-10 | Zimmer Biomet, Inc. | Lack of an adequate sterilization validation. |
| 2019-06-10 | Zimmer Biomet, Inc. | Lack of an adequate sterilization validation. |
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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.