FDA Device Intelligence
HomeHighridge Medical, LLC › FlareHawk

FlareHawk

Highridge Medical, LLC · Model ASY-00395 · UDI-DI 03662663087254

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

Description

#2 Ang. Curette

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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.