Devices

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
  • 1 Event

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

One device with a similar name

Learn more about the data here

Device Recall TLC Self Retaining Retractor System
  • Model / Serial
    Part #: M0068201750;   Part #: M0068201761;
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI. Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.
  • Product Description
    TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY || Product Usage: || Indicated to aid in tissue retraction during a surgical procedure.
  • Manufacturer
    Applied Medical Technology Inc