Events

Recall of Device Recall Synthes 5.0mm Variable Locking Screw

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
    67498
  • Event Risk Class
    Class 2
  • Event Number
    Z-1125-2014
  • Event Initiated Date
    2014-02-05
  • Event Date Posted
    2014-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125573
  • 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
    condylar plate fixation Implant - Product Code JDP
  • Reason
    Labeling correction: the package insert in one 5.0mm variable locking screw package was a gp0006 (anterior cervical vertebrae plate system) insert, which should have been a gp2848 (4.5mm va-lcp curved condylar plate system insert).
  • Action
    Synthes sent an Urgent Field Safety Notification/Medical Device Labeling Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Exchage the previously shipped package insert (GP0006) with the correct package insert (GP2848 provided with the notification). Review the package insert. Forward the Field Safety Notification to anyone in their facility that needs to be informed. If the package insert has been forwarded to another facility, contact that facility. Maintain awareness of this notice until all package inserts have been exchanged. Maintain a copy of the notice. Customers with questions were instructed to maintain a copy of the notice. For questions regarding this recall call 610-719-5000.

Device

Device Recall Synthes 5.0mm Variable Locking Screw
  • Model / Serial
    part no. 02.231.240, lot no. 823111
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including GA, CA, TX, MO, OH, PA, WA, AL, IN, AZ, MI, IA, TN, KY, NC, VA, NY, LA, IL, UT, and KS.
  • Product Description
    Synthes 5.0mm Variable Locking Screw || This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of the plate shaft.
  • 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