Events

Recall of Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar

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
    66581
  • Event Risk Class
    Class 2
  • Event Number
    Z-0404-2014
  • Event Initiated Date
    2013-10-14
  • Event Date Posted
    2013-11-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122646
  • 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
    Nail, fixation, bone - Product Code JDS
  • Reason
    Complaints were received reporting that a product packaged as a 14.5 mm outer protection sleeve for suprapatellar contained a 12.0 mm outer protection sleeve for suprapatellar.
  • Action
    Synthes sent an Urgent Notice: Medical Device Recall letter dated October 14, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 if they have any of the affected product to obtain a Return Authorization Number, complete the Verification Section at the end of the letter and return the Verification Form with the affected product to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 If customers do not have the affected product they should complete the attached Verification Section and return all documents to Synthes by: Fax: 866-229-7778 Scan/email: FieldAction@synthes.com Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.

Device

Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar
  • Model / Serial
    part no. 03010.438S, lot 706802
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar || Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft fractures, certain pre- and post- isthmic fractures, and tibial malunions and non-unions.
  • 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