Events

Recall of Ray TFC Device with End Caps

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
    49439
  • Event Risk Class
    Class 2
  • Event Number
    Z-0151-2009
  • Event Initiated Date
    2008-08-18
  • Event Date Posted
    2008-10-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73330
  • 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 - Product Code MAX
  • Reason
    The label on one side on the ray tfc device (ray cage) is incorrect. it reads 20 mm x 26 mm instead of 20 mm x 21 mm.
  • Action
    Urgent Product Recall notification letters were sent via Fed Express on August 18, 2008 to Stryker Branches and Hospital Risk Managers. The firm asked customers to examine their inventory and hospital locations to identify the product; reconcile all products on the Product Accountability Form and attached distribution sheet; and fax a copy of the Accountability Form and distribution sheet to Sarah Thompson within 5 days of receipt of the notice. All questions are to be directed to Susan Krasny at 201-760-8150.

Device

Ray TFC Device with End Caps
  • Model / Serial
    Lot code 07A259
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Ray TFC Device with End Caps: || Single Patient use; Sterile; || Stryker Spine || Ray Cage 7-2021 20 (catalog #) mm diameter x 21 mm long. || Ray Cages are indicated for use with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels for L2 to S1.
  • Manufacturer
    Stryker Spine

Manufacturer

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