Events

Recall of Device Recall Synthes 0.76 mm Drill Bit

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
    75694
  • Event Risk Class
    Class 2
  • Event Number
    Z-0681-2017
  • Event Initiated Date
    2016-11-01
  • Event Date Posted
    2016-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151063
  • 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
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Reason
    Package may be incorrectly labeled as containing 0.76 mm drill bit, but in fact contain a 1.1 mm diameter drill bit.
  • Action
    DePuy Synthes sent an Urgent Notice to customers affected by the recall to inform them of the potential impacts, and actions to be taken for the return of the identified units.

Device

Device Recall Synthes 0.76 mm Drill Bit
  • Model / Serial
    Model/Catalog # 316.15 Lot/Serial Number U172728
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed Nationwide
  • Product Description
    Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm || Non-Sterile
  • 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