FDA Recall
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.
Recall: Z-0686-2016
·
Initiated November 25, 2015
Recall
- Recall Number
- Z-0686-2016
- Event Number
- 72836
- Firm
- Abeon Medical Corporation
- FEI Number
- 3008657512
- Product Code
- KNT
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- November 25, 2015
- Terminated
- October 27, 2016
- Address
- 8000 Katherine Blvd, Brecksville, OH, 44141-4202
Description
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.
Reason
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
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.
Distribution
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.
Quantity
575 units