Events

Recall of Device Recall ConMed Hip Preservation System Signature Series

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ConMed Corporation.

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
    73123
  • Event Risk Class
    Class 2
  • Event Number
    Z-1842-2016
  • Event Initiated Date
    2015-12-21
  • Event Date Posted
    2016-05-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143103
  • 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
    Bur, surgical, general & plastic surgery - Product Code GFF
  • Reason
    Metal shavings released from burs during use are due to contact between the bur and the hood of the prebent bur assembly. during the manufacturing process an assembly error occurred which caused inadvertent mixing of two sizes of bearings.
  • Action
    ConMed sent an Urgent Medical Device Recall Notification letter dated December 17, 2015, to all affected customers. Customers are urged to stop use and return these devices immediately. Customers who have further distributed these items are urged to contact all of those organizations immediately and provide a copy of the recall notification letter. It is imperative that all end users of these devices receive the recall notice and respond immediately. Customers with questions can call 315-624-3237 or email largohpshb@conmed.com. The devices should be returned to ConMed Corporation NCR-47057 11155 Concept Blvd. Largo, FL 33773. For questions regarding this recall call 315- 624-3533.

Device

Device Recall ConMed Hip Preservation System Signature Series
  • Model / Serial
    Lot Numbers: 1) 569449, 577583, 577969, 579655, 580365, 581176, 581198, 582216, 587320, 594569, 658219, 669615, 673913 & 688136; 2) 569462, 577800, 577971 & 579652; 3) 569468, 577835, 577974, 579650, 583736, 583742, 587514, 627923, 659317 & 664751.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide to CA, CO, FL, IN, MD, MN, NC, NY, OH, TX, UT & VA; International: Canada, Wales
  • Product Description
    Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS-HB11, 2) PreBent Polishing Bur, 5.5mm x 19cm Catalog Number HPS-HB12 and 3) PreBent Oval Bur, 6.0mm x 19cm Catalog Number HPS-HB13 || The ConMed Hip Preservation System Signature Series is intended to be used for resection of osseous tissue (bone) in arthroscopic and endoscopic surgical procedures
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • Manufacturer Address
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA