Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
FDA Recall Z-1610-2016 · Posted None
Recalling FirmApplied Medical Technology Inc
Recall StatusTerminated
Product CodeGAD
Date Initiated2016-02-17
Date Terminated2016-10-27
Product Quantity2,263 Units
Reason for Recall
The firm received a complaint of an open pouch which breaches the sterilization validation.
Firm Action
AMT sent an Urgent Medical Device Recall letter dated February 17, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Service at 440-717-4000.
Root Cause
Packaging
Distribution Pattern
Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI. Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.