Zimmer Biomet (NYSE:ZBH) issued an urgent field safety notice in Europe to warn on certain StageOne and StageOne Select bone cement spacer molds due to potentially insufficient cleaning and monitoring.
According to the notice, certain devices may have undergone an insufficient cleaning process or were subject to potentially inadequate process monitoring for cleaning parameters.
More than 230,000 devices have been distributed and, to date, there have been five complaints involving events that may be associated with the issue. Zimmer Biomet is asking for the removal of the devices as a precautionary measure.
Users of the implants are advised to quarantine all potentially affected device(s) at their facility and alert their Zimmer Biomet sales representative so that the device(s) can be removed.
Zimmer Biomet’s orthopedic single-use silicone molds are designed to be filled with bone cement to create a temporary bone cement spacer for people undergoing a two-stage revision due to infection. The spacer typically remains in place for less than six months with partial weight-bearing until the second stage of the revision is performed and a conventional prosthesis is implanted.