Events

Recall of Device Recall Titanium Single Vector Distractor Body and Proximal Foot Plate

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes (USA) Products LLC.

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
    74419
  • Event Risk Class
    Class 2
  • Event Number
    Z-2585-2016
  • Event Initiated Date
    2016-05-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147496
  • 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
    External mandibular fixator and/or distractor - Product Code MQN
  • Reason
    Depuy synthes is voluntarily initiating a recall due to a possibility the fastener on the titanium single vector distractor body may become prematurely separated from the proximal foot plate.
  • Action
    The firm, DePuy Synthes, mailed out an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 5/23/2016 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review your inventory and immediately take the following actions: If you DO have any of the identified devices call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, complete the Verification Section (page 3 of the letter) indicating the number of devices that were found and return the Verification Section (page 3 of the letter) with the product to the following: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132, by fax 844-449-8498 or scan/email: Synthes8096@stericycle.com., and complete the Verification section even if you DO NOT have the identified product. Note: If the Verification Section is answered on behalf of more than one facility and/or individual clearly indicate the name and address of the facility and/or individual. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.

Device

Device Recall Titanium Single Vector Distractor Body and Proximal Foot Plate
  • Model / Serial
    Part # 487.974, Lot# A4JY041; 3949739; 4038565; 4044599; 4091233; 4600267; 4744818; 4745317; 4873173; 4873174; 5202231; 5202232; 5202233; 5202234; 5298113; 5304974; 5354033; 5469087; 5820678; 5860826; 6044556; 6199927; 6778533; 6877042; 6983832; 7492522; 7880980; 7931712; 9885355, mfg. date 11JUN1999 -21DEC2015, exp. date 20JUL2019-21DEC2035
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-US (nationwide) distribution to states of: AZ, CA, CO, DC, FL, IL, MA, MI, NJ, NY, PA, TX, UT, WI, and WV; and countries of: Australia, Canada and Switzerland.
  • Product Description
    TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 || The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • Manufacturer Address
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA