Events

Recall of Device Recall ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon Endo-Surgery Inc.

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
    59764
  • Event Risk Class
    Class 2
  • Event Number
    Z-3187-2011
  • Event Initiated Date
    2011-07-29
  • Event Date Posted
    2011-09-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103610
  • 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
    Staple, implantable - Product Code GDW
  • Reason
    Ethicon endo-surgery initiated a voluntary global recall for specific production lots of endopath¿ ets compact flex 45mm articulating linear cutters because the possibility exists that damage to the blister pack may have compromised the sterility of the device.
  • Action
    Ethicon Endo-Surgery Inc sent an URGENT DEVICE RECALL letter dated August 11, 2011 to all affected customers. The letter identified the product, the problem, the action to be taken by the customer. Customers were instructed to examine their inventory immediately to determine if they have any of the affected product. Fill out the Business Reply Form and fax it to 1-866-853-2802 if they have any of the affected product. To ensure adequate identification of the return product at their facility customers should complete the Customer Purchase Order Field on the Business Reply Form. For any questions regarding this recall call 1-866-708-2330 and reference Event 2471. For clinical or product support call 1-800-USE-ENDO, option 6, or contact your local sales representative.

Device

Device Recall ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters
  • Model / Serial
    Model # CTS45  Lot # F4PD36, Exp Date Jul-2014; Lot # F4PD9U, Exp Date Jul-2014; Lot # F4PG0X, Exp Date Aug-2014; Lot #, F4PG42, Exp Date Aug-2014; Lot # F4PG92, Exp Date Aug-2014; Lot # F4PH1N, Exp Date Aug-2014; Lot # F4PH4N, Exp Date Aug-2014; Lot # F4PJ4U, Exp Date Aug-2014; Lot # F4PK4W, Exp Date Aug-2014; Lot # F4PM4R, Exp Date Sep-2014; Lot # F4PM61, Exp Date Sep-2014; Lot # F4PN2E, Exp Date Sep-2014; Lot # F4PN8Z, Exp Date Sep-2014; Lot # F4PP1A, Exp Date Sep-2014; Lot # F4PP9F, Exp Date Sep-2014; Lot # F4PR1V, Exp Date Sep-2014; Lot # F4PU0Y, Exp Date Sep-2014; Lot # F4PU6Y, Exp Date Sep-2014; Lot # F4PV1E, Exp Date Oct-2014; Lot # F4PW2Z, Exp Date Oct-2014; Lot # F4PX14, Exp Date Oct-2014; Lot # F4PX5J, Exp Date Oct-2014; Lot # F4PX81, Exp Date Oct-2014; Lot # F4PY36, Exp Date Oct-2014; Lot # F4PY9W, Exp Date Oct-2014; Lot # F4PZ7L, Exp Date Oct-2014; Lot # F4PZ9H, Exp Date Oct-2014; Lot # F4R11D, Exp Date Nov-2014; Lot # F4R14L, Exp Date Nov-2014; Lot # F4R172, Exp Date Nov-2014; Lot # F4R213, Exp Date Nov-2014; Lot # F4R299, Exp Date Nov-2014; Lot # F4R31F, Exp Date Nov-2014; Lot # F4R435, Exp Date Nov-2014; Lot # F4R45U, Exp Date Nov-2014; Lot # G4R54T, Exp Date Dec-2014; Lot # G4R81J, Exp Date Dec-2014; Lot # G4R823, Exp Date Dec-2014; Lot # G4R971, Exp Date Dec-2014; Lot # G4R97A, Exp Date Dec-2014; Lot # G4R99A, Exp Date Dec-2014; Lot # G4RD0H, Exp Date Jan-2015; Lot # G4RD6P, Exp Date Jan-2015; Lot # G4RE6K, Exp Date Jan-2015; Lot # G4RG45, Exp Date Jan-2015; Lot # G4RG7C, Exp Date Jan-2015; Lot # G4RH07, Exp Date Jan-2015; Lot # G4RH1E, Exp Date Jan-2015; Lot # G4RL49, Exp Date Feb-2015; Lot # G4RM0M, Exp Date Feb-2015; Lot # G4RN6U, Exp Date Feb-2015; Lot # G4RN81, Exp Date Feb-2015; Lot # G4RP03, Exp Date Feb-2015; Lot # G4RP4M, Exp Date Feb-2015; Lot # G4RP8C, Exp Date Feb-2015; Lot # G4RR9N, Exp Date Feb-2015; Lot # G4RT2F, Exp Date Feb-2015; Lot # G4RT7H, Exp Date Feb-2015; Lot # G4RU9U, Exp Date Mar-2015; Lot # G4RV45, Exp Date Mar-2015; Lot # G4RV6G, Exp Date Mar-2015; Lot # G4RV95, Exp Date Mar-2015; Lot # G4RW0J, Exp Date Mar-2015; Lot # G4RX6X, Exp Date Mar-2015; Lot # G4RY1G, Exp Date Mar-2015; Lot # G4RY2D, Exp Date Mar-2015; Lot # G4RY4N, Exp Date Mar-2015; Lot # G4RZ1U, Exp Date Mar-2015; Lot # G4T04U, Exp Date Apr-2015; Lot # G4T099, Exp Date Apr-2015; Lot # G4T12L, Exp Date Apr-2015; Lot # G4T159, Exp Date Apr-2015; Lot # G4T39L, Exp Date Apr-2015; Lot # G4T43Y, Exp Date Apr-2015; Lot # G4T48N, Exp Date Apr-2015; Lot # G4T553, Exp Date Apr-2015; Lot # G4T59H, Exp Date Apr-2015; Lot # G4T86K, Exp Date May-2015; Lot # G4T92W, Exp Date May-2015; Lot # G4T96N, Exp Date May-2015; Lot # G4TA3E, Exp Date May-2015; Lot # G4TC5W, Exp Date May-2015; Lot # G4TC82, Exp Date May-2015; Lot # G4TE91, Exp Date Jun-2015; Lot # G4TG0U, Exp Date Jun-2015; Lot # G4TK3C, Exp Date Jun-2015; Lot # G4TK5X, Exp Date Jun-2015; Lot # G4TL66, Exp Date Jul-2015; Lot # G4TL6N, Exp Date Jul-2015; Lot # G4TM1L, Exp Date Jul-2015; Lot # G4TN19, Exp Date Jul-2015; Lot # G4TN5F, Exp Date Jul-2015; Lot # G4TP0Y, Exp Date Jul-2015; Lot # G4TP51, Exp Date Jul-2015; Lot # G4TP88, Exp Date Jul-2015; Lot # G4TR5K, Exp Date Jul-2015 Lot # G4TR9T, Exp Date Jul-2015; Lot # G4TT8Z, Exp Date Jul-2015; Lot # G4TU1G, Exp Date Aug-2015; Lot # G4TU1J, Exp Date Aug-2015; Lot # G4TV44, Exp Date Aug-2015; Lot # G4TX08, Exp Date Aug-2015; Lot # G4TX3H, Exp Date Aug-2015; Lot # G4TZ93, Exp Date Aug-2015; Lot # G4U020, Exp Date Aug-2015; Lot # G4U10D, Exp Date Sep-2015; Lot # G4U13F, Exp Date Sep-2015; Lot # G4U19A, Exp Date Sep-2015; Lot # G4U22Z, Exp Date Sep-2015; Lot # G4U28H, Exp Date Sep-2015; Lot # G4U51C, Exp Date Sep-2015; Lot # G4U62P, Exp Date Sep-2015; Lot # G4U62V, Exp Date Sep-2015; Lot # G4U83X, Exp Date Oct-2015; Lot # G4U91N, Exp Date Oct-2015; Lot # G4U94C, Exp Date Oct-2015; Lot # G4UA7G, Exp Date Oct-2015; Lot # G4UC07, Exp Date Oct-2015; Lot # G4UC4D, Exp Date Oct-2015; Lot # G4UC88, Exp Date Oct-2015; Lot # G4UD43, Exp Date Oct-2015; Lot # G4UD5C, Exp Date Oct-2015; Lot # G4UG3F, Exp Date Nov-2015; Lot # G4UG3J, Exp Date Nov-2015; Lot # G4UG82, Exp Date Nov-2015; Lot # G4UH9L, Exp Date Nov-2015; Lot # H4315X, Exp Date Dec-2015; Lot # H4317R, Exp Date Dec-2015; Lot # H4320H, Exp Date Dec-2015; Lot # H43303, Exp Date Dec-2015; Lot # H43369, Exp Date Dec-2015; Lot # H43409, Exp Date Dec-2015; Lot # H43436, Exp Date Dec-2015; Lot # H4351F, Exp Date Dec-2015; Lot # H43914, Exp Date Jan-2016; Lot # H43966, Exp Date Jan-2016; Lot # H43985, Exp Date Jan-2016; Lot # H43A2A, Exp Date Jan-2016; Lot # H43A4W, Exp Date Jan-2016; Lot # H43C68, Exp Date Jan-2016; Lot # H43E38, Exp DateFeb-2016; Lot # H43F4A, Exp Date Feb-2016; Lot # H43F6N, Exp Date Feb-2016; Lot # H43H3M, Exp Date Feb-2016; Lot # H43H64, Exp Date Feb-2016; Lot # H43H8J, Exp Date Feb-2016; Lot # H43J4N, Exp Date Feb-2016; Lot # H43M40, Exp Date Mar-2016; Lot # H43N4D, Exp Date Mar-2016; Lot # H43N5P, Exp Date Mar-2016; Lot # H43P11, Exp Date Mar-2016; Lot # H43R8Y, Exp Date Apr-2016; Lot # H43T5E, Exp Date Apr-2016; Lot # H43U8W, Exp Date Apr-2016; Lot # H43V5H, Exp Date Apr-2016; Lot # H43W06, Exp Date Apr-2016; Lot # H43W6C, Exp Date Apr-2016; Lot # H4402J, Exp Date May-2016; Lot # H4404X, Exp Date May-2016; Lot # H44303, Exp Date May-2016; Lot # H44369, Exp Date Jun-2016; Lot # H44604, Exp Date Jun-2016 and Lot # H4465K, Exp Date Jun-2016.   Model # CTS45NK  Lot # G4TZ37, Exp Date Aug-2015; Lot # G4UC08, Exp Date Oct-2015; Lot # H43A10, Exp Date Jan-2016 and Lot # H43W25, Exp Date Apr-2016.  Model # 6CB45  Lot # F4PE3Z, Exp Date Aug-2014; Lot # F4PH99, Exp Date Aug-2014; Lot # F4PR04, Exp Date Sep-2014; Lot # F4PX54, Exp Date Oct-2014; Lot # F4R204, Exp Date Nov-2014; Lot # G4R554, Exp Date Dec-2014; Lot # G4RD0F, Exp Date Jan-2015; Lot # G4RF4W, Exp Date Jan-2015; Lot # G4RJ23, Exp Date Jan-2015; Lot # G4RJ4D, Exp Date Jan-2015; Lot # G4RM6R, Exp Date Feb-2015; Lot # G4RR8N, Exp Date Feb-2015; Lot # G4RT26, Exp Date Feb-2015; Lot # G4RV11, Exp Date Mar-2015; Lot # G4RW1U, Exp Date Mar-2015; Lot # G4TJ4J, Exp Date Jun-2015; Lot # G4TN2N, Exp Date Jul-2015; Lot # G4TV1Z, Exp Date Aug-2015; Lot # G4UA7F, Exp Date Oct-2015; Lot # G4UC4C, Exp Date Oct-2015; Lot # H4345P, Exp Date Dec-2015 and Lot # H43L03, Exp Date Mar-2016.  Model # SCB45  Lot # F4PE3E, Exp Date Aug-2014; Lot # F4PL2N, Exp Date Aug-2014; Lot # F4PL31, Exp Date Sep-2014; Lot # F4PU2W, Exp Date Sep-2014 and Lot # F4PV36, Exp Date Oct-2014.  Model # SCG45  Lot # F4PL3M, Exp Date Sep-2014; Lot # F4PU2X, Exp Date Sep-2014; Lot # F4PX78, Exp Date Oct-2014; Lot # G4R72N, Exp Date Dec-2014; Lot # G4RC02, Exp Date Dec-2014; Lot # G4RJ3X, Exp Date Jan-2015; Lot # G4RL3U, Exp Date Feb-2015; Lot # G4RW9M, Exp Date Mar-2015; Lot # G4TC56, Exp Date May-2015; Lot # G4TR5C, Exp Date Jul-2015; Lot # G4UD5R, Exp Date Oct-2015; Lot # H43753, Exp Date Jan-2016; Lot # H43E0M, Exp Date Feb-2016 and Lot # H43L83, Exp Date Mar-2016.  Model # SCW45  Lot # F4PD3H, Exp Date Jul-2014; Lot # F4PE5V, Exp Date Aug-2014; Lot # F4PF5T, Exp Date Aug-2014; Lot # F4PL3P, Exp Date Sep-2014; Lot # F4PM1H, Exp Date Sep-2014; Lot # F4PU40, Exp Date Sep-2014; Lot # F4PV44, Exp Date Oct-2014; Lot # F4PW81, Exp Date Oct-2014; Lot # F4R15T, Exp Date Nov-2014; Lot # F4R27D, Exp Date Nov-2014; Lot # F4R352, Exp Date Nov-2014; Lot # G4R69T, Exp Date Dec-2014; Lot # G4R809, Exp Date Dec-2014; Lot # G4RC03, Exp Date Dec-2014; Lot # G4RF2X, Exp Date Jan-2015; Lot # G4RJ4K, Exp Date Jan-2015; Lot # G4RL44, Exp Date Feb-2015; Lot # G4RM75, Exp Date Feb-2015; Lot # G4RP7N, Exp Date Feb-2015; Lot # G4RU54, Exp Date Mar-2015; Lot # G4RX1E, Exp Date Mar-2015; Lot # G4RX62, Exp Date Mar-2015; Lot # G4T14R, Exp Date Apr-2015; Lot # G4T63F, Exp Date Apr-2015; Lot # G4TA7E, Exp Date May-2015; Lot # G4TF2K, Exp Date Jun-2015; Lot # G4TM93, Exp Date Jul-2015; Lot # G4TX42, Exp Date Aug-2015; Lot # G4U04J, Exp Date Sep-2015; Lot # G4U164, Exp Date Sep-2015; Lot # G4U74G, Exp Date Oct-2015; Lot # G4UA6K, Exp Date Oct-2015; Lot # H4305X, Exp Date Dec-2015; Lot # H4324F, Exp Date Dec-2015; Lot # H4329P, Exp Date Dec-2015; Lot # H43755, Exp Date Jan-2016; Lot # H43C2U, Exp Date Jan-2016; Lot # H43H0K, Exp Date Feb-2016; Lot # H43M8E, Exp Date Mar-2016; Lot # H43R6T, Exp Date Apr-2016 and Lot # H4406Z, Exp Date May-2016.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI and WV and the countries of ARGENTINA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, CZECH REPUBLIC, GREECE, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LIBYAN ARAB JAMAHIRIYA, MALAYSIA, MEXICO, POLAND, PUERTO RICO, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SPAIN, THAILAND and UNITED ARAB EMIRATES
  • Product Description
    ENDOPATH¿ ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCW45; CTS45; SCB45; CTS45NK; 6CB45 and SCG45. Mfr. By: Ethicon Endo-Surgery, LLC, Guaynabo, PR 00969 || The ETS Compact-Flex45 Articulating Linear Cutter is intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Manufacturer Address
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA