Events

Recall of Device Recall Orthopedic Devices

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
    72553
  • Event Risk Class
    Class 2
  • Event Number
    Z-0323-2016
  • Event Initiated Date
    2015-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141513
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    It was discovered that the above part number and lot of 2.4mm locking screws may contain the incorrect package insert (gp2613, va-lcp distal radius system). the correct package insert for the above part is gp2615 (modular mini fragment lcp system).
  • Action
    Synthes sent an "URGENT FIELD SAFETY NOTIFICATION" letter dated November 2, 2015. Customers were asked to take the following actions: -Review the correct package insert (GP2615, attached). -If found, discard incorrect package insert associated with the locking screw noted in the table above. -Forward this Field Safety Notification to anyone in your facility that needs to be informed. -If the package insert has been forwarded to another facility, contact that facility. -Complete the attached Verification Section (page 3 of this notification). Please include your name, title, address, telephone number and signature in the spaces provided. ---Send a copy of the completed Verification Section by: -Fax: 877-907-7514 or Scan/email: Synthes7766@stericycle.com -If the Verification Form is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in page three (3) of this notification. -Maintain a copy of this Notification.

Device

Device Recall Orthopedic Devices
  • Model / Serial
    Part Number Lot Number Product Description 212.818 7856527 Synthes 2.4mm Locking Screw SLF-TPNG with Stardrive Recess 18mm
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of IA, OH, CO, FL, TX, MA, NY, OR, SC, VA, WV, TN, MO, PA, CT, GA, WA, CA, AL, , IN, MI, NJ, VT, ID, KS, MN, and MD, and the country of Canada.
  • Product Description
    2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
  • 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