Events

Recall of Device Recall TLC SelfRetaining Retractor Frames

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abeon Medical Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72836
  • Event Risk Class
    Class 2
  • Event Number
    Z-0685-2016
  • Event Initiated Date
    2015-11-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142335
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Retractor, self-retaining - Product Code FFO
  • Reason
    The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
  • 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.

Device

Device Recall TLC SelfRetaining Retractor Frames
  • Model / Serial
    Part Number TLC200: Lot # 14121931 Exp Date 2017/12, Lot # 14121932 Exp Date 2017/12, Lot # 15010126 Exp Date 2018/01, Lot # 15013122 Exp Date 2018/01, Lot # 15013123 Exp Date 2018/01, Lot # 15024395 Exp Date 2018/02, Lot # 15024396 Exp Date 2018/02, Lot # 15031873 Exp Date 2018/03, Lot # 15032061 Exp Date 2017/12, Lot # 15034503 Exp Date 2017/10, Lot # 15040520 Exp Date 2018/02, Lot # 15041108 Exp Date 2017/12, Lot # 15044716 Exp Date 2018/04, Lot # 15050175 Exp Date 2018/01, Lot # 15051473 Exp Date 2018/05, Lot # 15051950 Exp Date 2018/04, Lot # 15054517 Exp Date 2018/05, Lot # 15062732 Exp Date 2018/04, Lot # 15070461 Exp Date 2018/02, Lot # 15070515 Exp Date 2018/02, Lot # 15076498 Exp Date 2018/07, Lot # 15080317 Exp Date 2018/01, Lot # 15090148 Exp Date 2018/07, Lot # 15090422 Exp Date 2018/03, Lot # 15092264 Exp Date 2018/01, Lot # 15095598 Exp Date 2018/09, Lot # 15102039 Exp Date 2018/05, Lot # 15103106 Exp Date 2018/09 & Lot # 15103112 Exp Date 2018/09.  Part Number TLC300: Lot # 14122483 Exp Date 2017/12, Lot # 15010125 Exp Date 2018/01, Lot # 15010989 Exp Date 2017/12, Lot # 15023291 Exp Date 2017/10, Lot # 15034288 Exp Date 2018/03, Lot # 15034509 Exp Date 2017/12, Lot # 15033742 Exp Date 2018/03, Lot # 15042675 Exp Date 2018/03, Lot # 15053401 Exp Date 2017/12, Lot # 15054441 Exp Date 2018/01, Lot # 15062598 Exp Date 2018/06, Lot # 15062599 Exp Date 2018/06, Lot # 15064578 Exp Date 2018/01, Lot # 15070470 Exp Date 2018/03, Lot # 15070490 Exp Date 2018/03, Lot # 15081541 Exp Date 2018/03, Lot # 15082695 Exp Date 2018/03, Lot # 15090147 Exp Date 2018/06, Lot # 15095188 Exp Date 2018/06, Lot # 15110466 Exp Date 2018/06 & Lot # 15110476 Exp Date 2018/06.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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 Description
    TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) || Indicated to aid in tissue retraction during a surgical procedure.
  • Manufacturer
    Abeon Medical Corporation

Manufacturer

Abeon Medical Corporation
  • Manufacturer Address
    Abeon Medical Corporation, 8000 Katherine Blvd, Brecksville OH 44141-4202
  • Manufacturer Parent Company (2017)
    Abeon Medical Corporation
  • Source
    USFDA