Integra poised to take $60 million hit following voluntary recall of devices manufactured at Boston facility

Integra LifeSciences is poised to take a financial hit totaling tens of millions of dollars following recent voluntary recalls. 

Initiated on May 22, the recalls pertain to all soft tissue repair products manufactured at the company's Boston facility over the last five years. Integra made the move following an internal investigation that revealed excess levels of endotoxins in the products. Deviations from the recommended specifications could cause immune responses that trigger postoperative fevers in patients, the company stated. 

Production of Integra’s SurgiMend, PriMatrix, Revize and TissueMend products has been temporarily halted due to the recalls, but the company said it has not received any customer complaints. 

“Although there is no specific indication of any reported product complaints related to high endotoxin levels, the Company, in accordance with its commitment to patient safety and product quality, has decided to initiate the voluntary recall and extend the temporary halt of manufacturing at its Boston facility to implement additional detection and quality controls,” the recall reads. “The company expects to resume manufacturing at its Boston facility following implementation of such controls.” 

The affected products manufactured at the Boston facility represent approximately 5% of Integra’s consolidated revenues. If production remains sidelined for the rest of 2023, Integra estimates that its earnings will be negatively impacted by approximately $60 million, as it anticipates the need for additional testing and validation beyond 2023. 

The company anticipates providing an updated assessment of its full-year guidance during their second quarter 2023 financial earnings conference call. 

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