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Synicem 72 Knee Trial FDA

BIOCOMPOSITES LTD · Model 885420 · UDI-DI 15060155712366

LXH Prescription

510(k) clearances

81,213

Adverse events (55 deaths)

526

Recalls

1,115

Facilities

Description

Reusable Knee Trial Spacer allows for the selection of the correct knee spacer to avoid manipulation prior to implantation during a 2-step revision knee arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “Knee Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.

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.