ADVANSYS®
NEWDEAL · Model 188202ND · UDI-DI 10381780042334
FSM
Prescription
10
510(k) clearances
2,357
Adverse events (2 deaths)
40
Recalls
876
Facilities
Description
The midfoot implant container is used in the transport and the sterilization of the non sterile implants and their associated instruments. It includes one base with reference 188212ND, one screw rack with reference 188216ND, one lid with reference 996200ND and one carpet with reference 188219ND. The transport and sterilization containers are not intended to maintain sterility.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-16 | Howmedica Osteonics Corp. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m |
| 2026-09-16 | Howmedica Osteonics Corp. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m |
| 2026-09-16 | Howmedica Osteonics Corp. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m |
| 2026-09-16 | Howmedica Osteonics Corp. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m |
| 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. |
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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.