Biomet Orthopedics ZFA 2019-00136 Various Biomet Products

A supplier who performs final cleaning operations on certain Zimmer Biomet products received an FDA Warning Letter earlier this year. Zimmer Biomet recently completed an assessment of that supplier following awareness of the Warning Letter. The assessment focused on devices processed prior to upgrades to the cleaning process, which began in March 2018. The assessment identified that the clinical history of devices processed within that timeframe experienced expected performance, based on independent national registry data and 57 global complaints for events associated with the risks identified below from over 200,000 devices distributed. However, the supplier’s associated quality standards at that time were not aligned with Zimmer Biomet’s current quality standards. As a result, the previous cleaning process could result in elevated levels of bacterial endotoxin and residual debris remaining on the devices. While these elevated levels could result in a local tissue reaction, there is not an elevated risk of infection as the sterility of the devices is not impacted. Out of an abundance of caution, Zimmer Biomet has made the decision to remove the devices that were processed by this supplier and not further processed through the upgraded Zimmer Biomet cleaning. Devices processed by the upgraded cleaning process, and outside of the affected lot numbers, are not impacted by this action.