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SI-BONE, Inc. initiated a voluntary Class II recall of 98 iFuse TORQ implants from specific lots due to tube packaging…
SIBNSI-BONE, Inc.
SI-BONE, Inc. initiated a voluntary Class II recall of 98 iFuse TORQ implants from specific lots due to tube packaging failures that compromised sterility. Two implants had already been implanted in patients; no infections have been reported. The company expects approximately 3,900 total implants to require repackaging and re-sterilization. SI-BONE anticipates recording an aggregate gross charge of up to $150,000 in the third and fourth quarters for recall and remediation costs, with potential recovery sought from the tube manufacturer. The company does not believe this will materially impact revenue or its ability to provide implants. Separately, SI-BONE entered into a Fourth Amendment to Lease extending its Santa Clara headquarters lease by one month at $43,696 per month. SI-BONE, Inc. operates in the medical device industry, specializing in minimally invasive spine implant systems.