Z-0686-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2016
- Initiation Date
- November 25, 2015
- Termination Date
- October 27, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 575 units
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.
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.
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.
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.