Events

Recall of Synthes Spiked Washers 13.5/6.5

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes USA HQ, 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
    66580
  • Event Risk Class
    Class 2
  • Event Number
    Z-0394-2014
  • Event Initiated Date
    2013-10-03
  • Event Date Posted
    2013-11-26
  • 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=122645
  • 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
    Washer, bolt nut - Product Code HTN
  • Reason
    During a retrospective assessment, spiked washers 13.5/6.5 were discovered to be mislabeled as spiked washers 13.5/5.5.
  • Action
    SYNTHES sent an Urgent Notice: Medical Device Recall letter dated October 3, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product located. Return the Verification Form to: Credit/Returns Synthes 1101 Synthes Avenue, Monument, CO 80132 Customers were also asked to return the Verification Form indicating they did not have the affected product also. All documents were to be returned to Synthes by: Fax 1-877-270-5855 Scan/email: FieldAction@synthes.com Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant For questions regarding this recall call 610-719-5000..

Device

Synthes Spiked Washers 13.5/6.5
  • Model / Serial
    part 219.951 with multiple lot#:   2335941 2339634 2397429 2405812 2440475 2442736 2496414 5661855 5663841
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Synthes Spiked Washers 13.5/6.5 || Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
  • Manufacturer
    Synthes USA HQ, Inc.

Manufacturer

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