Events

Recall of Device Recall Surgical Saw Blade Procedure Pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synvasive Technology 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
    64646
  • Event Risk Class
    Class 2
  • Event Number
    Z-1127-2013
  • Event Initiated Date
    2013-03-14
  • Event Date Posted
    2013-04-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116702
  • 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
    Prosthesis, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
  • Reason
    Biomet part # 506076, lot 928182 was received from synvasive technology containing the incorrect blade.
  • Action
    An Urgent Medical Device Recall Notice letter dated March 21, 2013 was sent to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use; remove the products from inventory and complete and return the attached Response Form. For questions call 574-372-1570.

Device

Device Recall Surgical Saw Blade Procedure Pack
  • Model / Serial
    Biomet Product code: 506076, Lot 829182. Synvasive Part Number: 11-3629.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distributor including the state of IN
  • Product Description
    The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED || For use with Stryker System 5, System 4, System 2000 and EDH. || Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.
  • Manufacturer
    Synvasive Technology Inc

Manufacturer

Synvasive Technology Inc
  • Manufacturer Address
    Synvasive Technology Inc, 4925 Robert J Mathews Pkwy, El Dorado Hills CA 95762-5701
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA