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Terminated

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.

FDA Recall Z-0686-2016 · Posted None

Recalling FirmAbeon Medical Corporation
Recall StatusTerminated
Product CodeKNT
Date Initiated2015-11-25
Date Terminated2016-10-27
Product Quantity575 units

Reason for Recall

The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.

Firm Action

On 12/17/2015 the firm sent Recall Notification Letters to their customers. The letter identified the product, problem, and actions to be taken by the customer.

Root Cause

Packaging

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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