Events

Recall of PROXIMATE

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
    69109
  • Event Risk Class
    Class 2
  • Event Number
    Z-2610-2014
  • Event Initiated Date
    2014-08-12
  • Event Date Posted
    2014-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129655
  • 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
    Stapler, surgical - Product Code GAG
  • Reason
    The device may have a non-conforming component that may cause the device to fire an unformed staple.
  • Action
    The firm, Ethicon Endo-Surgery, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 25, 2014 to its customers via overnight, UPS to allow tracking of the receipt. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory to determine if you have recalled product on hand; remove the recalled product and communicate the issue to relevent staff; complete and return Business Reply Form (BRF) confirming receipt of this notice within three (3) business days, indicating whether they have affected product, how much and whether they will/have returned the product or whether they no longer have any of the recall product. The BRF may be sent to Stericycle by fax at 1-855-328-6659 or by email at ethicon3022@stericycle.com. Product replacement is available for customers who return unopened affected product. If you need clinical or product support, please contact your local sales representative or call our Customer Support Center at 1-877-ETHICON (1-877-384-4266). If you need additional shipping labels or a communications package, contact Stericycle at 1-855-328-0398 and reference Event 3022.

Device

PROXIMATE
  • Model / Serial
    PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35) Batch L4EG3F L4EK3Y L4EP22 L4ER1D L4ER9X L4EU87  PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35) Batch  L4EG2T L4EH20 L4EH85 L4EK50 L4EN58 L4EN94 L4EP2F L4EP6G L4ER1L L4EU0J L4EV07  Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117) Batch  L91J4U L91K38 L91K6N L91M8N L91N22 L91W33 L91X5V  Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158) Batch  L90W40 L90X3C L90Y0U L90Y4V L90Z7C L9108Z L91151 L91223 L91970 L91A7N L91C5C L91E2Z L91E6P L91G46 L91J4L L91K3A L91M4U L91T81
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY; and countries of: Armenia, Belgium, Germany, Denmark, Finland, France, UK, Italy, Japan, South Korea, Netherlands, Norway, Russia, Sweden, Singapore, Taiwan, Tanzania, and South Africa.
  • Product Description
    PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158). Skin stapler for use in a single patient, which is designed to apply rectangular stainless steel staples for routine wound closure.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

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