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Abeon Medical Corporation recalls Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY.
Recalled January 27, 2016 · FDA recall Z-0686-2016 · Abeon Medical
Hazard
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product. · FDA Class II
Units
575 units
Sold at
Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CT,FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, NC, NH, NJ, OH, SC, TN, TX, UT, VA & WI., and the countries of Austria, Germany, Italy, Japan, Spain, Sweden & Switzerland.
Description
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Product
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.
Manufacturer(s)
Abeon Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →