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ASCOT

SIGNUS Medizintechnik GmbH · Model Tap · UDI-DI 04047844121016

LXH Prescription
10
510(k) clearances
81,213
Adverse events (55 deaths)
526
Recalls
1,115
Facilities

Description

ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to accommodate anatomic requirements. Fixed and variable angle screws are available in numerous length/ diameter combinations. In addition, a center graft screw is offered.

Recalls

DateFirmReason
2026-07-01Biomet, Inc.Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused
2026-07-01Biomet, Inc.Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused
2026-07-01Biomet, Inc.Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused
2026-07-01Biomet, Inc.Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused
2026-07-01Biomet, Inc.Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused
2026-05-20United Orthopedic Corp.Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
2026-05-20United Orthopedic Corp.Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
2026-03-19United Orthopedic Corp.Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
2025-03-28Stryker GmbHThe metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
2025-03-28Stryker GmbHThe metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.

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Data 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.