Events

Recall of Device Recall Synthes 2.4mm VALCP Two Column Volar Distal Radius Plate and Torque limiting Attachment, 1.2Nm

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
    65556
  • Event Risk Class
    Class 2
  • Event Number
    Z-2057-2013
  • Event Initiated Date
    2013-05-31
  • Event Date Posted
    2013-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119565
  • 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
    Plate, fixation, bone - Product Code HRS
  • Reason
    The firm is initiating a field safety correction for the labeling of the 2.4mm va-lcp two column volar distal radius plate and 1.2 nm torque limiting attachment. the us technique guide lists 1.2nm tla as an option for use with the 2.4mm variable angle lcp (va-lcp) two-column (standard & narrow) volar distal radius plate. the potential exists for the va locking screw to be driven through the 2.4mm.
  • Action
    Synthes sent an Urgent Notice: Medical Device Labeling Correction letter dated May 31, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA as an option for use with the 2.4mm Variable Angle LCP (VA-LCP) Two-Column (Standard & Narrow) Volar Distal Radius Plate. The potential exists for the VA locking screw to be driven through the 2.4mm VA-LCP Two Column Volar Distal Radius Plate when used with a 1.2Nm Torque Limiting Attachment. A screw that passes through the VA-LCP plate is not likely to result in a serious adverse event although should it occur, additional medical intervention during the index procedure could be needed. If you have any questions, please call (610) 719-5450, or contact your Synthes sales Consultant.

Device

Device Recall Synthes 2.4mm VALCP Two Column Volar Distal Radius Plate and Torque limiting Attac...
  • Model / Serial
    Part number J8301-F
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including the states of AK. AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MD, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI SC, SD, TN, TX, UT, VA, VT, WA WI and WV.
  • Product Description
    Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm || Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
  • 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