Events

Recall of Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive

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
    60237
  • Event Risk Class
    Class 2
  • Event Number
    Z-0348-2012
  • Event Initiated Date
    2011-10-17
  • Event Date Posted
    2011-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104849
  • 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
    The potential exists for the large oscillating saw attachment to disengage from the small battery drive handpiece. if the attachment disengages from the handpiece, there is a potential for injury to the patient and/or user.
  • Action
    Synthes sent a "NOTICE: MEDICAL DEVICE RECALL" letter dated October 17, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The firm requests that customers return their affected device(s) for servicing. Instructions are provided for customers to follow. Customers having questions regarding this notice should contact the firm at 610-719-5450.

Device

Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive
  • Model / Serial
    Catalog number: 532.026 - All lots
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of CO, LA, NY, and OK.
  • Product Description
    Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive. || This surgical instrument motor and accessories are AC-powered, battery-powered or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw blade.
  • 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