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Zimmer Biomet, Inc. recalls StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposabl
Recalled November 14, 2018 · FDA recall Z-0399-2019 · Zimmer Biomet
Hazard
There is a potential for comingling of the 43MM and 51 MM molds · FDA Class II
Units
72 units
Sold at
US Nationwide Distribution in the states of: AZ, FL, MI, OH, VA & WI
Description
There is a potential for comingling of the 43MM and 51 MM molds
Product
StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed to be filled with polymethylmethacrylate/gentamicin bone cement, or equivalent, by injecting with a dispenser/gun into the mold. After the cement cures, the temporary spacers are to be removed from the molds with the reinforcement remaining as the core of the spacer, and placed into the joint space. The spacers remain in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional hip joint prosthesis.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →