Events

Recall of Device Recall OsteoClage Stainless Steel Bone Plate

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Acumed 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
    67885
  • Event Risk Class
    Class 2
  • Event Number
    Z-1515-2014
  • Event Initiated Date
    2014-03-26
  • Event Date Posted
    2014-04-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126557
  • 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
    Pin, fixation, smooth - Product Code HTY
  • Reason
    Manufacturing of these devices with a grade of stainless steel that is not within specifications.
  • Action
    Acumed sent an Urgent Medical Device Recall letter dated March 26, 2014 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers are instructed to immediately stop using and/or distributing all lots identified in the letter. Return affected products as instructed in the letter. For questions contact Acumed Business Service via email at BusinessService@acumed.net or via phone at 877-627-9957.

Device

Device Recall OsteoClage Stainless Steel Bone Plate
  • Model / Serial
    2.0mm x 80mm SS cable/sleeve: Lot # 222078, 232175, 245032, 254368, 261903, 270659, 284155, 297281.  2.0mm SS sleeve only: Lot # 247553, 267469, 280871, 313261.  8, 7 hole SS compression plate: Lot # 300381.  10, 9 hole SS compression plate: Lot # 299641.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY. Product was distributed outside the US to: Australia, China, Figi, France, Great Britain, Italy, Japan, Korea, Maylasia, Sweden, South Africa, Spain.
  • Product Description
    The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . || 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S || 2.0 mm SS Sleeve Only; Part Number 01-0022-S || 8, 7 hole, SS compression plate; Part Number 02-2007-S || 10, 9 hole, SS compression plate; Part Number 02-2009-S || Product Usage: The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate. It is used in conjunction with 4.5mm Cortical bone screws to provide compression across bone fractures. The Osteo-Clage Cerclage Wire Crimp sleeve is used in conjunction with the bone plate in cerclage fixation procedures
  • Manufacturer
    Acumed LLC

Manufacturer

Acumed LLC
  • Manufacturer Address
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9432
  • Manufacturer Parent Company (2017)
    Acumed Llc
  • Source
    USFDA