Events

Recall of Device Recall ACL DISPOSABLE PACK BONETENDONBONE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 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
    78668
  • Event Risk Class
    Class 2
  • Event Number
    Z-0838-2018
  • Event Initiated Date
    2017-11-17
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162100
  • 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
    Kit, surgical instrument, disposable - Product Code KDD
  • Reason
    Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. it is indicated to be a single surgery use, disposable set of instrumentation for anterior cruciate ligament (acl) reconstruction surgeries.
  • Action
    On about 11/17/2017 letters were sent by certified mail with tracking information to all domestic accounts and International Stryker sites were notified by email. Instructions include to inform individuals who need to be aware of the device recall, examine all stock areas and/or operating room storage for affected product quarantine and discontinue use of the recalled devices, complete the acknowledgement form, and if affected product is found contact Stryker customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return.

Device

Device Recall ACL DISPOSABLE PACK BONETENDONBONE
  • Model / Serial
    Model 0234020280, UDI 07613154643264, Lot No. 17299AG2
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed domestically to . Distributed internationally to Australia and Mexico.
  • Product Description
    ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
  • Manufacturer
    Stryker Corporation

Manufacturer

Stryker Corporation
  • Manufacturer Address
    Stryker Corporation, 5900 Optical Ct, San Jose CA 95138-1400
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA