Zimmer Biomet (ZBH) voluntarily recalled various legacy Biomet products due to cleaning processes that could lead to elevated bacterial endotoxins and residual debris. Affected products include various shoulder and elbow replacement components, hip and knee replacement components, trauma fixation devices and patient-matched/custom products for extremities, hips and knees.
ZBH completed an assessment of a supplier that performs final cleaning operations on certain ZBH products following awareness that the supplier received an FDA Warning Letter earlier this year. The assessment focused on devices processed prior to upgrades to the cleaning process, which began in March 2018.
The assessment revealed that the clinical history of devices processed before the upgrades experienced expected performance. However, the supplier’s associated quality standards at that time were not aligned with ZBH'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 caution, the company has removed devices that were processed by this supplier and not further processed through the upgraded ZBH cleaning system. Devices processed by the upgraded cleaning process, and outside of the affected lot numbers, are not impacted by this action.