Events

Recall of Ulnar Shortening Saw Blade

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
    55410
  • Event Risk Class
    Class 2
  • Event Number
    Z-1807-2010
  • Event Initiated Date
    2010-04-14
  • Event Date Posted
    2010-06-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90774
  • 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
    The saw blades may not cut aggressively enough for their intended application therefore creating a risk that the saw could generate excessive heat, which may contribute to bone necrosis and/or non-union.
  • Action
    On April 14, 2010, Acumed began contacting consignees by telephone. On April 15, 2010, Acumed sent out the URGENT NOTICE: DEVICE RECALL Initial Notification letter and Recalled Product Status Form to their consignees. The letter describes the recall product as Ulnar Shorting Saw Blade-Hub Style S, Part no. 80-0499-S and Lot Codes. The Initial Notification letter instructs consignees to return the product back to Acumed immediately and notify their sub-accounts (customers) if products have been further distributed. The consignees also are asked to fill out and send back the Recalled Product Status Form . Customers should call the Customer Service at 1-888-627-9957 or e-mail to RecallNotification@acumed.net for any questions regarding the recall.

Device

Ulnar Shortening Saw Blade
  • Model / Serial
    Part Number: 80-0499-S Lot Numbers: 214436, 215637, 215638, 215639, 215640, 215641, 219931, and 220909.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA and to the following countries: Spain, Great Britain, South Africa, Puerto Rico, Canada, Turkey, Ireland, Finland, Belgium, Australia, Germany, and Sweden.
  • Product Description
    Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, USA". || The Ulnar Saw Blade is an accessory used with a Congruent Bone Plate System covered under K012655, but it is labeled and sold separately by itself. || The saw blade is also sold as part of the Upper Extremity Osteotomy System (BOM 15-0030). The BOM 15-0030 system does not have a label, but the saw blade is individually labeled and shipped together with this system when it is ordered. || Intended use: Cutting Bones
  • 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