Events

Recall of Device Recall Synthes 2.4 and 2.7 MM Locking Screw SLFTPNG with T8 Stardrive Recess 12 MM

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
    66411
  • Event Risk Class
    Class 2
  • Event Number
    Z-0380-2014
  • Event Initiated Date
    2013-07-31
  • Event Date Posted
    2013-11-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122355
  • 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
    Specific lots of the ss 2.4mm and ss 2.7mm locking screw (self-tapping) due to a mislabeling issue. the ss 2.7mm screw was labeled as ss 2.4 mm screw.
  • Action
    Synthes sent an URGENT NOTICE: MEDICAL DEVICE RECALL letter dated July 31, 2013, to all affected customer. 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 Nuber, complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Fax the documents to Synthes at 1-866-792-6446 or email to 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

Device Recall Synthes 2.4 and 2.7 MM Locking Screw SLFTPNG with T8 Stardrive Recess 12 MM
  • Model / Serial
    Lot 3420620
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including PA, CA, FL, MO, KS, IN, IL, WV, KY, LA, NM, SC, IA, TX, AZ, GA, NC, OK, NY, TN, MI, CO, and MT.
  • Product Description
    2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM || Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
  • 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