Z-0686-2016Class II

Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY...

Name: Z-0686-2016 Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY...
Creator: Abeon Medical Corporation
Published: 2015-11-25
License: https://open.fda.gov/license/

Abeon Medical Corporation / initiated 2015-11-25 / Terminated / root cause: packaging

FDA source

Abeon Medical Corporation began a recall of Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid in tissue retraction... on 2015-11-25. FDA classified it as Class II and gives the reason as "The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0686-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-25
Posted: 2016-01-21
Terminated: 2016-10-27
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.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
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.
Root cause tag: packaging
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0686-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0684-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-21
Z-0685-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-21
Z-0686-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-21

Product code KNT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)