Events

Recall of Device Recall Acumed Tension Band Pin

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-1516-2014
  • 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=126602
  • 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
    Certain lots of acumed tension band pins are being recalled because the implantable product was manufactured 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 Acumed Tension Band Pin
  • Model / Serial
    50.0 mm Tension Band Pin: Lot 243639 70.0 mm Tension Band Pin: Lots 241127, 242707, 243325, 243948. 90.0 mm Tension Band Pin: Lots 241128. 242708, 243327, 243949.  50.0 mm Tension Band Kit: Lots 216769, 217002, 217941, 219145, 219402, 222732, 223007, 224312, 229889, 232575, 235490, 237772, 244800, 246204, 247056.  70.0 mm Tension Band Kit: Lots 210290, 211349, 214574, 215405, 217004, 218273, 219230, 220978, 221503, 223008, 223477, 224066, 225554, 227193, 229394, 230287, 230952, 231971, 233742, 235502, 237773, 240512, 241185, 243617, 243945, 244801, 246777, 246779, 246938, 247108, 247109, 247493.  90.0 mm Tension Band Kit: Lots 215053, 217005, 218600, 218700, 221465, 222731, 223009, 223756, 225555, 228951, 231573, 236969, 237774, 243620, 244802, 246939, 246990, 247381.
  • 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 Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. || 50.0 mm Tension Band Pin; Part Number 30-0097 || 70.0 mm Tension Band Pin; Part Number 30-0098 || 90.0 mm Tension Band Pin; Part Number 30-0099 || 50.0 mm Tension Band Kit; Part Number TB-1550K-S || 70.0 mm Tension Band Kit; Part Number TB-1570K-S || 90.0 mm Tension Band Kit; Part Number TB-1590K-S || Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine.
  • 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