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FIXED CASE

Bradshaw Medical, Inc. · Model MRS-104-01 · UDI-DI 00810019931482

LXH

510(k) clearances

82,132

Adverse events (55 deaths)

526

Recalls

1,119

Facilities

Description

Fixed case or Fixed frame is a specialized part of a modular retractor system. Its function is to provide a rigid, stationary base of support for the entire retractor assembly. It is securely attached to the operating room table rail or a similar fixed point.

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.