Events

Recall of Device Recall Acetabular Pressurizer 0206522000

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
    66444
  • Event Risk Class
    Class 2
  • Event Number
    Z-0280-2014
  • Event Initiated Date
    2013-11-01
  • Event Date Posted
    2013-11-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122400
  • 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
    On march 14, 2013 a work order was opened for 120 units (20 boxes) of the acetabular pressurizer (p/n 0206-522-000 rev. h). on march 15, 2013, when the product was going to be placed in the pouch to be sealed, the manufacturing operator noticed that some assemblies were cracked. as a result of the injection pressure of the cement gun, a cracked tiplet may release from the hub during cement applica.
  • Action
    The firm, Stryker Instruments, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 11/01/2013, to all domestic consignees/customers and an email was sent to the International Subsidiaries and Sales Representatives. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Immediately review this Recall Notification 2. Immediately check all stock areas and/or operating room storage and quarantine any affected product found. 3. Complete the enclosed Business Reply Form to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the Business Reply Form even if you don't have any affected product on hand. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in this Notification. 4. If you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF) to all affected locations. Please indicate each location on the BRF. 5. Fax the completed Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762. 6. Upon receipt of the Business Reply Form, if you have recalled product on hand, Stryker will email a pre-paid shipper. This shipper can be used to return the recalled Acetabular Pressurizers to Stryker. 7. Upon receipt of recalled Acetabular Pressurizers, credit will be applied to your account. For questions regarding this recall please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) at 269-389-2921 or email: kellyjo.whipple@stryker.com.

Device

Device Recall Acetabular Pressurizer 0206522000
  • Model / Serial
    Part number: 0206-522-000 and lots: 08183012, 08310012, 09237012, 10243012, 11109012, 11353012, and 12216012
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including states of: TX, FL, IL, IA, ND, WI, VA, and NJ.; and countries of: CANADA, POLAND and SWITZERLAND.
  • Product Description
    Acetabular Pressurizer; single use and six units per box. || The Acetabular Pressurizer 0206-522-000 is an accessory to the || Advanced Cement Mixer (ACM). The Acetabular Pressurizer || Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-522-000. || This Acetabular Pressurizer is an accessory used to pressurize the cement applied to the prosthesis to be implanted during the surgery. The Acetabular Pressurizer is an injection molded component made with resin material DOW HDPD 10462N which is a rigid plastic once it is molded.
  • 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