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ROD-GRIPPER LUMBAR DUAL ACTION 5.5MM SILICONE OVERMOLD

Bradshaw Medical, Inc. · Model RGV-01-01-550-00-A · UDI-DI 00810019932908

LXH Prescription
10
510(k) clearances
81,662
Adverse events (55 deaths)
526
Recalls
1,117
Facilities

Description

A lumbar spinal fixation component, the ROD-GRIPPER, featuring a dual-action locking mechanism and a 5.5mm silicone overmold. Designed to provide secure rod fixation within lumbar spinal constructs.

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.