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Modular Retractor System

Bradshaw Medical, Inc. · Model MRS-100 · UDI-DI 00810019932502

LXH

510(k) clearances

81,662

Adverse events (55 deaths)

526

Recalls

1,117

Facilities

Description

The Intech Modular Retractor System was developed in close cooperation with leading Medical Device companies and surgeons to serve a variety of approaches to the spine. This versatile kit allows for a variety of configurations (1, 2, or 4 blades) to allow the surgeon safe and efficient access to the spine for implant placement. 1 kit with infinite possibilities (i.e.. Midline, pedicle-based and 3 to 4 blades retractor configurations...)

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.