Zimmer Biomet (NYSE:ZBH) last week released a letter advising hospitals and surgeons that it would be recalling various Legacy Biomet products that underwent cleaning processes that could result in elevated levels of bacterial endotoxin and residual debris.
Warsaw, Ind.-based Zimmer Biomet said a supplier who performs final cleaning operations on some of its products received a warning letter from the FDA earlier this year. The cleaning process with the unnamed supplier began in March 2018, according to the letter.
Zimmer Biomet conducted an assessment of the supplier, focusing on devices prior to upgrades to the cleaning process. The company found that the devices processed within that timeframe underwent expected performance, but claimed the supplier’s associated quality standards “were not aligned” with Zimmer Biomet’s.
The findings showed that, as a result, the cleaning process could result in the heightened levels of bacterial endotoxin and debris remaining on the devices. Zimmer Biomet said the elevated levels could result in a local tissue reaction, but there is not an elevated risk of infection because the sterility of the devices was not impacted.
Zimmer Biomet said it removed the devices processed by the supplier that were not processed through the company’s upgraded cleaning process.
In May, the FDA sent a warning letter to Orchid Orthopedic Solutions highlighting alleged violations, including unsanitary water used to clean implants. There is no known connection between Zimmer Biomet and Orchid, but the warning letter to Orchid called attention to the investigation into the company, in which the FDA found that Orchid failed to sanitize its water system in the event of bacterial endotoxin excursion.
Shares of ZBH were up +2.5% at $137.47 per share in mid-afternoon trading today.