Events

Recall of Device Recall AVS TL Trial Spacer

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
    55710
  • Event Risk Class
    Class 2
  • Event Number
    Z-1963-2010
  • Event Initiated Date
    2010-05-13
  • Event Date Posted
    2010-07-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91653
  • 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
    Orthopedic Manual Surgical Instrument - Product Code MDM
  • Reason
    Stryker spine has received reports of breakage of the distal end of the avs tl spacer trial during the trialling step of the avs tl procedure.
  • Action
    Urgent Product Recall letters, dated May 13, 2010 were sent via Federal Express to all direct accounts (branches and hospitals) with a separate letter to surgeons. The letter identified the affected product and also described the issue, potential hazards, and risk mitigations. The letter also asked customers to quarantine any affected product and return to Stryker Spine. A Customer Response Form was provided and customers should contact their Stryker Spine Sales Rep for additional information on replacement product. Questions should be directed to Tiffani Rogers on 201-760-8206.

Device

Device Recall AVS TL Trial Spacer
  • Model / Serial
    Lot numbers: 063937 - 066353 - 067533 - 067534 - 06D473 - 071449 - 073985 - 074602 - 075345 - 076574 - 07C639 - 07H722 - 082969 - 084255.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Stryker 13 MM AVS TL Trial Spacer; Catalog number: 48389413. || Manufactured by: Stryker Spine SAS, Cestas, France; || Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401. || Intended for use in the thoraco-lumbar spine.
  • Manufacturer
    Stryker Spine

Manufacturer

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