Oto-Med—Sheehy, Cox, and spineX Bone Dust Collectors: Sterility May Be Compromised

December 16, 2020 | Strategic Insights for Health System


ECRI's complete weekly summary of medical device hazard and recall information is available in ECRI's Health Device Alerts. For more information contact us at clientservices@ecri.org.

In a December 7, 2020, Urgent Product Recall Notice Immediate Action Required letter submitted by ECRI member hospitals, Oto-Med states that a hole may develop in the packaging of the above bone dust collectors during handling/shipment, rendering the product non-sterile. Oto-Med also states that it has received no reports of adverse events associated with this problem. The manufacturer has not confirmed the...

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