Abeon Medical Corporation: Medical Device Recall in 2016 - (Recall #: Z-0686-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: November 25, 2015

Date Posted: January 27, 2016

Recall Number: Z-0686-2016

Event ID: 72836

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.

Status: Terminated

Product Quantity: 575 units

Code Information:

Part Number TLC5042: Lot # 14121931 Exp Date 2017/12, Lot # 15010126 Exp Date 2018/01, Lot # 15013122 Exp Date 2018/01, Lot # 15013123 Exp Date 2018/01, Lot # 15021046 Exp Date 2018/01, Lot # 15021051 Exp Date 2018/01, Lot # 15024395 Exp Date 2018/02, Lot # 15031873 Exp Date 2018/03, Lot # 15033220 Exp Date 2018/02, Lot # 15040515 Exp Date 2017/06, Lot # 15044161 Exp Date 2017/12, Lot # 15044717 Exp Date 2018/04, Lot # 15050167 Exp Date 2017/12, Lot # 15051473 Exp Date 2018/05, Lot # 15051474 Exp Date 2018/05, Lot # 15062728 Exp Date 2017/12, Lot # 15070483 Exp Date 2018/01, Lot # 15070485 Exp Date 2018/01, Lot # 15074959 Exp Date 2018/07, Lot # 15075862 Exp Date 2018/01, Lot # 15076498 Exp Date 2018/07, Lot # 15080211 Exp Date 2018/01, Lot # 15080251 Exp Date 2018/01, Lot # 15081546 Exp Date 2018/01, Lot # 15093692 Exp Date 2018/01, Lot # 15094993 Exp Date 2018/01, Lot # 15095115 Exp Date 2018/07, Lot # 15095135 Exp Date 2018/03, Lot # 15095190 Exp Date 2017/12, Lot # 15100494 Exp Date 2018/10 & Lot # 15110293 Exp Date 2018/06. Part Number TLC5042-I: Lot # 15010126 Exp Date 2018/01, Lot # 15021046 Exp Date 2018/01, Lot # 15023295 Exp Date 2017/06, Lot # 15042815 Exp Date 2018/01, Lot # 15044716 Exp Date 2018/04, Lot # 15044717 Exp Date 2018/04, Lot # 15080659 Exp Date 2018/04 & Lot # 15082266 Exp Date 2018/04.

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.

Voluntary or Mandated:

Voluntary: Firm initiated