ADVANSYS®
NEWDEAL · Model 188211ND · UDI-DI 10381780042341
FSM
Prescription
10
510(k) clearances
2,280
Adverse events (2 deaths)
36
Recalls
875
Facilities
Description
The stainless steel base is part of the container with reference 188201ND used in the transport and the sterilization of the associated non sterile implants. It is composed of one base and two silicone bumpers to securely maintain the devices. 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.