Events

Recall of Device Recall Low Profile U Joint Driver for the SynFix Mini Open System

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

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
    50523
  • Event Risk Class
    Class 2
  • Event Number
    Z-0931-2009
  • Event Initiated Date
    2008-11-20
  • Event Date Posted
    2009-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75693
  • 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
    Lumbar Intervertebral Fusion Device with Bone Graft - Product Code MAX
  • Reason
    Screwdriver tip may break off and lodge in the screw head.
  • Action
    The recalling firm emailed all Spine Sales Consultants on 11/20/08. They were instructed to immediately examine their stock and discuss appropriate technique with surgeon users. In addition, a Medical Device Correction letter dated 11/19/08 was issued via USPS certified mail to the medical facilities. This initial letter stated the issue and requested the users take the following actions: discard all SynFix Technique Guides and replace with the updated literature contained in the mailing packet with the letter, and is identified by code J7022-E (Rev. E); to ensure receipt and understanding of the information, the Verification Section of the letter needs to be completed and returned to Synthes by either fax: 610-719-5120 or scan/e-mail: lewis.lynne@synthes.com. An Urgent: Medical Device Recall letter, dated 1/16/2009, was also sent out. This latter letter requested that users examine their stock immediately and remove any of the affected devices from their inventory. Customers are also to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number; complete the Verification Section; and return the letter with the recalled product to the address listed. There are also actions for those who do not have the affected product. Questions should be directed to 800-620-7025 x 5453 or 610-719-5453.

Device

Device Recall Low Profile U Joint Driver for the SynFix Mini Open System
  • Model / Serial
    Lot numbers: 2317363, 2331806, 2331810, 2387975, 2387976, 2401982, 5637286, 5644605, 5660377, 5664629, 5826243, and 5826244.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Class II Recall - Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA ,SC, TN, TX, UT, VA, WA, and WI, and countries of Canada and Switzerland.
  • Product Description
    Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231. || The Synthes SynFix LR is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFix LR can be packed with autograft.
  • Manufacturer
    Synthes Spine

Manufacturer

Synthes Spine
  • Manufacturer Address
    Synthes Spine, 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA