PlainRecalls
FDA Devices Moderate Class II Terminated

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 i

Reported: November 14, 2018 Initiated: September 21, 2018 #Z-0399-2019

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
72 units
Distribution
US Nationwide Distribution in the states of: AZ, FL, MI, OH, VA & WI
Location
Warsaw, IN

Frequently Asked Questions

What product 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.. Recalled by Zimmer Biomet, Inc.. Units affected: 72 units.
Why was this product recalled? ▼
There is a potential for comingling of the 43MM and 51 MM molds
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 14, 2018. Severity: Moderate. Recall number: Z-0399-2019.

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