Events

Recall of Device Recall Stryker Reliance AL Implant Blocker

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker 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
    62415
  • Event Risk Class
    Class 2
  • Event Number
    Z-2176-2012
  • Event Initiated Date
    2011-03-21
  • Event Date Posted
    2012-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110439
  • 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
    Instrument, manual, surgical, general use - Product Code MDM
  • Reason
    Stryker spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument.
  • Action
    Stryker sent an Urgent Product Recall letters/return response forms dated April 5, 2012, via FedEX to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and hospital location to identify the product. Reconcile any SLIDE Implant Blockers with catalog and lot numbers referenced above. Retrieve and return the affected product using the enclosed pre-paid mailing label to Stryker Spine 59 Route 17 South, Allendale, New Jersey, 07401. For questions customers were instructed to call 201-760-8298.

Device

Device Recall Stryker Reliance AL Implant Blocker
  • Model / Serial
    Catalog Number: 48361223, 48361224, 48361225, 48361226, 48361227, 48361228 Lot Code: 084505, 084506, 084507, 084508, 084509, 084510
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including NC, AR, TN, MA, IL, GA, NY, LA, MN, MO, OH, KS, NM, TX, KS,and IN.
  • Product Description
    Stryker Reliance AL Implant Blocker (Various sizes) || The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use. It allows the surgeon to distract the disc space in the lumbar region of the spine using an anterior or anterolateral approach while also allowing them to insert the implant into final position.
  • Manufacturer
    Stryker Spine

Manufacturer

Stryker Spine
  • Manufacturer Address
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA