Events

Recall of Device Recall Spectrum Designs MedicalNasal Dorsal Columella Implant

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spectrum Designs 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
    44735
  • Event Risk Class
    Class 2
  • Event Number
    Z-1264-2007
  • Event Initiated Date
    2007-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64329
  • 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
    Nasal Dorsal Columella Implant, - Product Code LZK
  • Reason
    Mispackaging/mislabeling: a portion of packaged nasal lot 31053 contained chin implants instead of the nasal implant.
  • Action
    The firm initiated the recall on 07/24/2007 by contacting the customer (distributor) who filed the original complaint of mislabeling by email. The firm followed-up by sending recall letters (dated July 24, 2007) via FedEx or certified mail with signature confirmation to the one other direct account who received the recalled product on 08/03/2007. Customers were instructed to check their inventory for mislabeled products and call Spectrum at (800)239-6399 to report the number of this product being returned. They were given an address for product return. The firm indicated they will examine returned products, and scrap after examination.

Device

Device Recall Spectrum Designs MedicalNasal Dorsal Columella Implant
  • Model / Serial
    Catalog Number: S400-314S and Lot #31053; Serial Numbers: BAG612 ,BAG6I3, BAG6I4, BAG652, BAG654 and BAG655
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide: California and China
  • Product Description
    Spectrum Designs Medical-Nasal Dorsal Columella Implant, Catalog Number: S400-314S and Lot #31053; Serial Numbers: BAG612 ,BAG6I3, BAG6I4, BAG652, BAG654 and BAG655
  • Manufacturer
    Spectrum Designs Inc

Manufacturer

Spectrum Designs Inc
  • Manufacturer Address
    Spectrum Designs Inc, 6387 Rose Ln Ste B, Carpinteria CA 93013-2937
  • Source
    USFDA