Events

Recall of Device Recall Universal Spinal System Lamina Hooks

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes (USA) Products 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
    62324
  • Event Risk Class
    Class 2
  • Event Number
    Z-2054-2012
  • Event Initiated Date
    2012-05-31
  • Event Date Posted
    2012-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110226
  • 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
    Orthosis, spinal pedicle fixation - Product Code MNI
  • Reason
    Uss lamina hooks, medium, right are being recalled because the hooks are etched with the wrong part number - 498.321 (lamina hook, medium, left). the lamina hooks should be etched with part number 498.320 (lamina hook, medium, right).
  • Action
    SYNTHES sent a Medical Device Recall letter dated May 31, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested consignees and sales reps remove recalled product from their inventory, call the firm at 1-800-479-6329 to receive an authorization number and complete the enclosed verification form and return to: Credit/Returns, Synthes 1101 Synthes Avenue Monument, Colorado 80132. If customers do not have any of the affected product they were instructed to complete the Verification Section at the end of the letter by checking the appropirate box indicating that no affected porudct has been located. Return the document to Synthes by fax to 610-251-9005 or Scan/Email: FieldAction@synthes.com. For any questions please call 610-719-5450.

Device

Device Recall Universal Spinal System Lamina Hooks
  • Model / Serial
    Catalog number 498.321, lot/serial #6876785
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including GA, PA, SC, TX, and UT and Canada.
  • Product Description
    Universal Spinal System Lamina Hooks || Synthes Medium TI Lamina Hook - Right || 498.320 || Non sterile || LOT 6876785 || Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature patients with the exception of the small stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of these indications: degenerative disc disease, spondylolisthesis, trauma, deformities or curvatures, tumor, stenosis and failed previous fusion.
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • Manufacturer Address
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA