Recall Z-0686-2016 — Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid in tissue retraction during a surgical procedure.
U.S. FDA — Device Enforcement · United States · 2015-11-25 · Class II
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Reported risk: The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
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