🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: November 25, 2015 Abeon Medical Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Abeon Medical Corporation
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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 Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0686-2016

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