Stryker—Duracon Augments: Tyvek Lid May Be Punctured, Potentially Compromising Product Sterility

September 30, 2015 | Strategic Insights for Health System


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In a September 22, 2015, Urgent Medical Device Recall Notification letter submitted by an ECRI Institute member hospital, Stryker states that it has received 2 reports of the tibial wedge prostheses listed below puncturing the packaging's Tyvek lids, potentially compromising sterility. In both cases, the puncture was discovered in the operating room (OR) and a new device was opened and used. The manufacturer has not confirmed the...

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