Events

Recall of Device Recall MAKOplasty Hip Array Kit Laminate

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mako Surgical 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
    73199
  • Event Risk Class
    Class 2
  • Event Number
    Z-1588-2016
  • Event Initiated Date
    2015-11-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144392
  • 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 stereotaxic instrument - Product Code OLO
  • Reason
    Stryker orthpaedics became aware that there is the potential for the 210540 makoplasty hip array kit laminate 150230 to list two part numbers for the rio base array, which is item #5 on the product table.
  • Action
    On 12/09/2015, Product Field Action Letters and Product Accountability forms were sent to Branch/Agencies via overnight courier with a return receipt; Hospital Risk Management were sent Notification letters and a Product Recall Acknowledgement form with return receipt on 12/9;/2015.

Device

Device Recall MAKOplasty Hip Array Kit Laminate
  • Model / Serial
    Catalog No. 210540, Lot Code: 150324
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CO, KY, MN, WA and WV
  • Product Description
    MAKOplasty Hip Array Kit Laminate 150230
  • Manufacturer
    Mako Surgical Corporation

Manufacturer

Mako Surgical Corporation
  • Manufacturer Address
    Mako Surgical Corporation, 2555 Davie Rd Ste 110, Plantation FL 33317-7424
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA