Stryker—Duracon Augments: Tyvek Lid May Be Punctured, Potentially Compromising Product Sterility
September 30, 2015 | Risk Management News
ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at firstname.lastname@example.org.
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...