StageOne Hip recalled over mold contamination

Recall date

September 21, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Zimmer Biomet, Inc. recalls StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables ma…

Recall number

Z-0399-2019

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

US Nationwide Distribution in the states of: AZ, FL, MI, OH, VA & WI

Why it was recalled

There is a potential for comingling of the 43MM and 51 MM molds

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.