Events

Recall of Device Recall Stryker PCD Precision System 13G Needle with Spineplex

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Div. of Stryker Corporation.

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
    60586
  • Event Risk Class
    Class 2
  • Event Number
    Z-0862-2012
  • Event Initiated Date
    2011-11-30
  • Event Date Posted
    2012-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105884
  • 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
    Mixer, cement, for clinical use - Product Code JDZ
  • Reason
    Product was packaged with a four inch needle in stead of the correct five inch needle. there is a potential that the needle may not be able to reach the fracture site, which may require additional medical intervention. in addition, if the stylet needs to be changed and the additional stylet that comes in the package is used, this additional stylet is one inch longer than the needle. which could l.
  • Action
    Stryker sent an Urgent Recall Notification letter dated December 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. If product was further distributed, customers should forward the recall notification letter and the attached Business Reply Form (BRF) to all affected locations. Immediately check inventory and quarantine any affected product found. Mark product as "RECALLED PRODUCT". Indicate on the BRF the quantity of affected PCD kits they are returning and fill in the form completely. Fax the Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762. Upon receipt of the BRF, Stryker will contact them to coordinate the return of all affected product that they have on hand. For questions regarding this recall call 269-389-4354. .

Device

Device Recall Stryker PCD Precision System 13G Needle with Spineplex
  • Model / Serial
    Part Number 0505-585-000, Lot 11223012  13G Match Ground Four facet Tip Introduction Needle - PIN 0306-130-011 13G Bevel Tip Stylet - PIN 0306-131-012
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including FL, PA, NY, OH, IL, KY, MT, WA, CA, MO, HI, IN, SC, MS, WV, KS, TX, and WY
  • Product Description
    Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable , 4 units per box. units per box. Stryker Instruments, Kalamazoo, MI || Part Number: 0505-585-000, Lot:11223012 || 13G Match Ground Four facet Tip Introduction Needle - PIN 0306-130-011 || 13G Bevel Tip Stylet - PIN 0306-131-012 || The intended use of the Stryker PCD System is for mixing bone cement and delivering it percutaneously. Bone cement is mixed in the chamber then transferred directly into an extension nozzle which has been attached to the introduction needle in the fracture site by a luer lock fitting. Cement is then dispensed directly into the fracture site under fluoroscopy
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA