Events

Recall of Radiolucent Retractor for Upper Cervical Spine

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes, 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
    69432
  • Event Risk Class
    Class 2
  • Event Number
    Z-0092-2015
  • Event Initiated Date
    2014-10-02
  • Event Date Posted
    2014-10-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130528
  • 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 - Product Code GAD
  • Reason
    Particle residue on the instrument from adhesive tape which was used to bind the device during transport. there may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy.
  • Action
    DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated October 2, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please take the following actions: If you DO have any of the identified devices, please take the following steps: Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. Send a copy of the completed Verification Section to DePuy Synthes by: Fax: (610) 430-7083 or " Scan/email: Fieldaction@synthes.com Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 3 of the notification. If you DO NOT have the identified product, please take the following steps: Complete the attached Verification Section (page 3 of this letter) by checking the appropriate box indicating that no affected product has been located. Please include your name, title, address, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device removal information. Return the documents to DePuy Synthes by Fax: (610) 430-7083 or Scan/email: Fieldaction@sythes.com Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 3 of the notification. If you have any questions, please call 610-719-5450, or contact your DePuy Synthes sales consultant. Thank you for your attention to this issue.

Device

Radiolucent Retractor for Upper Cervical Spine
  • Model / Serial
    Radiolucent Retractor for Upper Cervical Spine part number 387.580, lot number 3620715.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of PA, NC, TN, NY, WI, WA and MI.
  • Product Description
    DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
  • Manufacturer
    Synthes, Inc.

Manufacturer

Synthes, Inc.
  • Manufacturer Address
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA