Events

Recall of Device Recall Alphatec Souls Proximal/Distal Deployment Wrench

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alphatec Spine, 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
    61756
  • Event Risk Class
    Class 2
  • Event Number
    Z-1676-2012
  • Event Initiated Date
    2012-03-19
  • Event Date Posted
    2012-05-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108936
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Reason
    Alphatec spine has received several complaints (n+4) on the alphatec solus distal deployment wrench for twisting or bending, which has been discovered either during or after instrumentation use. a fifth complaint received in which it was reported that the spline tip of the alphatec solus proximal deployment wrench had sheared from the instrument upon use.
  • Action
    Alphatec Spine sent an Urgent Medical Device Recall Notification dated March 30, 2012, to all affected customers. The notification letter informed customers of the removal/recall and included instructions on what to do with the recalled products. Initial letter was delivered via FedEx, and followed by telephone call with a total of 4 attempts. Customers were instructed to return all of the affected product. Upon receipt of of the Medical Device Recall Notification, customers were instructed to contact Alphatec Spine's Customer Service Department immediately for instructions on how to return the instruments and fill out the lower portion of this letter to confirm that they have read the notification and have taken all necessary removal actions: Customers should return a signed copy of the form to: Alphatec Spine, Inc. 5818 El Camino Real, Carlsbad, CA 92008 ATTN: Rand Jadan Forms may also be returned via email to rjadan@alphatecspine.com or fax to 760-431-0289. For questions regarding this recall call 760-431-9286.

Device

Device Recall Alphatec Souls Proximal/Distal Deployment Wrench
  • Model / Serial
    Part Numbers: 25975 & 25976. Product Code(s): MAX. Market Clearance: 510(k) K102402.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and Germany
  • Product Description
    SOLUS Anterior Lumbar Interbody Fusion Spinal || Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402. || The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondyiolisthesis or retrolisthesis at the involved level(s). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades. The Alphatec Solus implant is intended for use with supplemental spinal fixation. Specifically, the Alphatec Solus implant is to be used with the Alphatec's Zodiac¿ Spinal Fixation System, Aspida" Anterior Lumbar Plating System, or the ILLlCO¿ MIS Posterior Fixation System. Intervertebral body fusion device.
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • Manufacturer Address
    Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad CA 92008-8816
  • Manufacturer Parent Company (2017)
    Alphatec Holdings Inc.
  • Source
    USFDA