Events

Recall of Device Recall Synthes

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
    67261
  • Event Risk Class
    Class 2
  • Event Number
    Z-1057-2014
  • Event Initiated Date
    2014-01-07
  • Event Date Posted
    2014-02-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125106
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    The synthes driving cap/threaded can bind in the im nail radiolucent insertion handles when assembled becoming difficult to separate.
  • Action
    Synthes sent an Urgent Notice - Medical Device Recall Letter dated January 7 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Action to be taken: Our records indicate that your facility has the product(s) subject to this Recall. Synthes asks that you review your inventory and immediately remove the affected lots from stock. 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 Number. "Complete the Verification Section at the end 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, telephone number and signature in the spaces provided. "Return the Verification Form (page-3 of this letter) with the product to: "Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If you DO NOT have the identified product, please take the following steps: "Complete the attached Verification Section at the end of this letter by checking the appropriate box indication that no affected product has been located. :Please include your name, title, 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: 877-271-1473 or " Scan/email: FieldAction@synthes.com If you have any questions,please call 610-719-5450. Thank you for your attention to this issue.

Device

Device Recall Synthes
  • Model / Serial
    Part No. 03.010.523, Lot Nos. 8279162 & 8429004
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA (nationwide) Distribution.
  • Product Description
    Synthes Driving Cap/Threaded || Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.
  • 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