Events

Recall of Device Recall 4.5mm TI Multiloc Screw Length 38MM

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
    62307
  • Event Risk Class
    Class 2
  • Event Number
    Z-2059-2012
  • Event Initiated Date
    2012-05-22
  • Event Date Posted
    2012-07-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110178
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Reason
    Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.
  • Action
    Synthes sent a "NOTICE: MEDICAL DEVICE RECALL" letter dated May 22, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Verification Form was enclosed for customers to complete and return via fax to 610-251-9005. Contact the firm at 610-719-5450 for questions regarding this recall.

Device

Device Recall 4.5mm TI Multiloc Screw Length 38MM
  • Model / Serial
    Lot #2724103 Expiration 4/29/2012 REF 04.019.038S
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, LA, MD, MN, NJ, NY, OH, PA, TN, TX, and VA.
  • Product Description
    4.5mm TI Multiloc Screw Length 38MM-Sterile || Expiration: 04/29/2012 || REF 04.019.038S || Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 || 4.5MM TI Multiloc Screw Length 38MM-Sterile || Ref 04.019,038S. || The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head, below the articular surface).
  • 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