FDA Medical Device Recalls (openFDA)
Abeon Medical Corporation: 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 number
- Z-0686-2016
- Recalling firm
- Abeon Medical Corporation
- Product
- 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.
- Status
- Terminated
- Initiated
- 2015-11-25
- Posted
- not on file
- Terminated
- 2016-10-27
- Reason
- The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
- Root cause
- Packaging
- 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.
- Quantity
- 575 units
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 3008657512
- Firm city
- Brecksville
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28