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Impact

NVision Biomedical Technologies, Inc. · Model PP-1001T-CUT3 · UDI-DI 00810135963374

LXH Prescription

510(k) clearances

82,132

Adverse events (55 deaths)

526

Recalls

1,119

Facilities

Description

PEEK Nail Cutter 3.0mm The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

Recalls

Date	Firm	Reason
2026-07-01	Biomet, 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
2026-07-01	Biomet, 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
2026-07-01	Biomet, 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
2026-07-01	Biomet, 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
2026-07-01	Biomet, 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
2026-05-20	United Orthopedic Corp.	Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
2026-05-20	United Orthopedic Corp.	Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
2026-03-19	United Orthopedic Corp.	Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
2025-03-28	Stryker GmbH	The 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.
2025-03-28	Stryker GmbH	The 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.