Events

Recall of Device Recall TLC Self Retaining Retractor System

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-0684-2016
  • 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=142334
  • 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 Self Retaining Retractor System
  • Model / Serial
    Part Number M0068201750: Lot # 14112171 Exp Date 2017/11, Lot # 14112177 Exp Date 2017/11, Lot # 14120576 Exp Date 2017/05, Lot # 14120579 Exp Date 2017/11, Lot # 14121661 Exp Date 2017/12, Lot # 14121862 Exp Date 2017/12, Lot # 14121863 Exp Date 2017/12, Lot # 15010199 Exp Date 2017/12, Lot # 15010200 Exp Date 2017/12, Lot # 15011528 Exp Date 2018/01, Lot # 15011529 Exp Date 2018/01, Lot # 15011530 Exp Date 2018/01, Lot # 15011531 Exp Date 2018/01, Lot # 15012638 Exp Date 2017/12, Lot # 15012640 Exp Date 2017/11, Lot # 15013724 Exp Date 2017/11, Lot # 15013788 Exp Date 2018/01, Lot # 15013789 Exp Date 2018/01, Lot # 15013790 Exp Date 2018/01, Lot # 15013791 Exp Date 2018/01, Lot # 15020046 Exp Date 2018/01, Lot # 15020047 Exp Date 2017/12, Lot # 15020048 Exp Date 2018/01, Lot # 15021047 Exp Date 2018/01, Lot # 15021049 Exp Date 2018/01, Lot # 15021472 Exp Date 2018/02, Lot # 15021473 Exp Date 2018/02, Lot # 15021474 Exp Date 2018/02, Lot # 15024336 Exp Date 2018/01, Lot # 15030309 Exp Date 2018/01, Lot # 15030310 Exp Date 2017/11, Lot # 15030317 Exp Date 2018/01, Lot # 15032508 Exp Date 2018/03, Lot # 15034955 Exp Date 2018/03, Lot # 15035013 Exp Date 2018/03, Lot # 15040424 Exp Date 2018/02, Lot # 15040425 Exp Date 2018/01, Lot # 15040426 Exp Date 2018/01, Lot # 15040681 Exp Date 2018/04, Lot # 15040682 Exp Date 2018/04, Lot # 15041220 Exp Date 2018/04, Lot # 15050026 Exp Date 2018/01, Lot # 15050027 Exp Date 2018/03, Lot # 15050029 Exp Date 2018/03, Lot # 15061724 Exp Date 2018/04, Lot # 15061725 Exp Date 2018/04, Lot # 15082274 Exp Date 2018/04, Lot # 15082325 Exp Date 2018/04, Lot # 15082326 Exp Date 2018/05, Lot # 15082837 Exp Date 2018/08, Lot # 15082838 Exp Date 2018/08, Lot # 15082839 Exp Date 2018/08, Lot # 15084674 Exp Date 2018/08, Lot # 15084675 Exp Date 2018/08, Lot # 15084676 Exp Date 2018/08, Lot # 15084745 Exp Date 2018/08, Lot # 15084945 Exp Date 2018/08, Lot # 15084946 Exp Date 2018/08, Lot # 15090470 Exp Date 2018/08, Lot # 15090472 Exp Date 2018/08, Lot # 15090479 Exp Date 2018/08, Lot # 15090653 Exp Date 2018/09, Lot # 15092097 Exp Date 2018/09, Lot # 15092098 Exp Date 2018/09, Lot # 15092099 Exp Date 2018/09, Lot # 15092487 Exp Date 2018/08, Lot # 15092488 Exp Date 2018/08, Lot # 15092498 Exp Date 2018/09, Lot # 15092500 Exp Date 2018/09 & Lot # 15100350 Exp Date 2018/09.  Part Number M0068201761: Lot # 14112771 Exp Date 2017/11, Lot # 14112177 Exp Date 2017/11, Lot # 14120578 Exp Date 2017/11, Lot # 14121661 Exp Date 2017/12, Lot # 14121861 Exp Date 2017/12, Lot # 15011528 Exp Date 2018/01, Lot # 15011530 Exp Date 2018/01, Lot # 15011531 Exp Date 2018/01, Lot # 15012621 Exp Date 2017/12, Lot # 15013728 Exp Date 2017/12, Lot # 15013788 Exp Date 2018/01, Lot # 15013791 Exp Date 2018/01, Lot # 15020050 Exp Date 2017/09, Lot # 15021047 Exp Date 2018/01, Lot # 15021048 Exp Date 2018/01, Lot # 15021050 Exp Date 2018/01, Lot # 15021472 Exp Date 2018/02, Lot # 15021473 Exp Date 2018/02, Lot # 15021474 Exp Date 2018/02, Lot # 15030318 Exp Date 2018/01, Lot # 15032367 Exp Date 2018/01, Lot # 15032370 Exp Date 2018/01, Lot # 15032507 Exp Date 2018/03, Lot # 15034955 Exp Date 2018/03, Lot # 15040428 Exp Date 2018/02, Lot # 15040681 Exp Date 2018/04, Lot # 15040682 Exp Date 2018/04, Lot # 15041281 Exp Date 2018/04, Lot # 15042333 Exp Date 2018/03, Lot # 15045081 Exp Date 2018/04, Lot # 15050030 Exp Date 2018/01, Lot # 15061726 Exp Date 2017/12, Lot # 15082837 Exp Date 2018/08, Lot # 15082839 Exp Date 2018/08, Lot # 15084674 Exp Date 2018/08, Lot # 15084675 Exp Date 2018/08, Lot # 15084946 Exp Date 2018/08, Lot # 15084947 Exp Date 2018/08, Lot # 15090461 Exp Date 2018/08, Lot # 15090480 Exp Date 2018/08, Lot # 15092097 Exp Date 2018/09 & Lot # 15092499 Exp Date 2018/08.
  • 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 System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. || Indicated for use in the retraction of soft tissue away from the operative surface.
  • 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